case study

Quality Management System

Small or emerging life science organizations often put off hiring quality executives, exposing the company to risk or worse. Other organizations add full-time leaders before they have full-time needs, resulting in over-spending. This case study suggests another model: variable outsourcing of quality leadership to best match needs and spending.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Quality Management System

Client

Fortune 500 manufacturer of consumer products in need of quality management system support. 

Industry

Medical Device

Business Challenge

Regulatory requirements for Design Master Record and Design History File for product launch of a new medical device

Project Timeline

3 months

About QMS for Medical Devices

The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).

Client Challenge

A fortune 500 consumer products company was planning new product development for their initial foray into the medical device space. Their product launch design team was introducing an innovative therapy for home use. Recognizing that risk insulation and speed to market would be critical for early adoption and success, the parent company decided to create a new subsidiary to develop and launch the product.

The seasoned Quality Assurance (QA) management elected to stay with the fortune 500 enterprise instead of joining the subsidiary, whereas some of the early and mid-careerists were attracted to the start-up venture. The subsidiary realized they had staff to implement but lacked QA leadership and deep medical device expertise.

Product Development Process

Regulatory Compliance Associates® Inc. (RCA) was engaged to recommend and establish a compliant Quality System. Thinking it would be faster than starting afresh, the subsidiary had initially proposed adoption of the parent company’s QS. RCA evaluated the legacy QS and found it lacking the medical device requirements. Over the course of 90 days, RCA developed a Quality Management System including the following elements:

  • Management representative role
  • Risk Management file and activities
  • Design History File including documentation of user needs and design inputs, design outputs, design verification and validation protocols and reports, and design reviews
  • Drafting and implementing QS standard operating procedures
  • Document Control and Quality Records processes and records
  • Device Master Record
  • Design Change process and records
  • Manufacturing Design transfer plans

To accomplish the resulting Quality Management System system, see figure 1 below, RCA provided the subsidiary with experts in product design, including mechanical electrical, software and user advocates, as well as experts in quality systems and design history files.

regulatory compliance

 

Results

With RCA’s outsourced QA expertise and product launch implementation staff, the subsidiary was able to launch the product without hiring expensive executives. Additionally, some of the subsidiary staff saw RCA as mentors, used this opportunity to enrich their skills, and increased their contribution to the organization.

Over time, there were some internal promotions within the QA team as RCA helped create a culture of grooming and promoting from within. The subsidiary continued their engagement with RCA to enrich their Quality Management System with subsequent phases. Most importantly, the transitional quality process control, Product Complaint Handling, CAPA, Quality Manual, Regulatory Reporting, Internal Audits, Post Production and Management Review.

As these milestones were achieved and as company sales grew, the subsidiary became attractive to investors and was sold to an established medical device company.

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

Quality Assurance

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

Remediation Support

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

About Regulatory Compliance Associates

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Client

Fortune 500 manufacturer of consumer products in need of quality management system support. 

Industry

Medical Device

Business Challenge

Regulatory requirements for Design Master Record and Design History File for product launch of a new medical device

Project Timeline

3 months

About QMS for Medical Devices

The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).

Client Challenge

A fortune 500 consumer products company was planning new product development for their initial foray into the medical device space. Their product launch design team was introducing an innovative therapy for home use. Recognizing that risk insulation and speed to market would be critical for early adoption and success, the parent company decided to create a new subsidiary to develop and launch the product.

The seasoned Quality Assurance (QA) management elected to stay with the fortune 500 enterprise instead of joining the subsidiary, whereas some of the early and mid-careerists were attracted to the start-up venture. The subsidiary realized they had staff to implement but lacked QA leadership and deep medical device expertise.

Product Development Process

Regulatory Compliance Associates® Inc. (RCA) was engaged to recommend and establish a compliant Quality System. Thinking it would be faster than starting afresh, the subsidiary had initially proposed adoption of the parent company’s QS. RCA evaluated the legacy QS and found it lacking the medical device requirements. Over the course of 90 days, RCA developed a Quality Management System including the following elements:

  • Management representative role
  • Risk Management file and activities
  • Design History File including documentation of user needs and design inputs, design outputs, design verification and validation protocols and reports, and design reviews
  • Drafting and implementing QS standard operating procedures
  • Document Control and Quality Records processes and records
  • Device Master Record
  • Design Change process and records
  • Manufacturing Design transfer plans

To accomplish the resulting Quality Management System system, see figure 1 below, RCA provided the subsidiary with experts in product design, including mechanical electrical, software and user advocates, as well as experts in quality systems and design history files.

regulatory compliance

 

Results

With RCA’s outsourced QA expertise and product launch implementation staff, the subsidiary was able to launch the product without hiring expensive executives. Additionally, some of the subsidiary staff saw RCA as mentors, used this opportunity to enrich their skills, and increased their contribution to the organization.

Over time, there were some internal promotions within the QA team as RCA helped create a culture of grooming and promoting from within. The subsidiary continued their engagement with RCA to enrich their Quality Management System with subsequent phases. Most importantly, the transitional quality process control, Product Complaint Handling, CAPA, Quality Manual, Regulatory Reporting, Internal Audits, Post Production and Management Review.

As these milestones were achieved and as company sales grew, the subsidiary became attractive to investors and was sold to an established medical device company.

 

About RCA’s Medical Device Consulting Services

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

Quality Assurance

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

Remediation Support

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

About Regulatory Compliance Associates

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

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