case study

MDR Regulatory Submission

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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MDR Regulatory Submission

Client

Global medical device organization based in USA in need of EU MDR support. 

Project Timeline

Regulatory Documentation – 4 weeks

Clinical Evaluation Report – 6 weeks

EU MDR Submission – 4 months

Client Challenge

A global medical device firm needed to meet the regulatory EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge based on localities. Based on the new CE mark regulatory articles, the client moved from a self-submission regulatory status to a Class 1 device, and the new regulatory information was needed.

RCA Approach

Preparation and consulting time was spent with the client’s leadership team to create a cohesive strategy based on the new EU MDR regulatory environment.

Regulatory Strategy

Training meetings were conducted between RCA life science consultants and the client to explain the new changes from MDD and MDR, and what path to regulatory compliance was needed. The current state assessment involved the Design History File and the current state of QMS.

Standard Operating Procedure (SOP)

A Project Plan was developed that outlined the development or revision of 12 Standard Operating Procedures, and development of complete design history files for 3 current/legacy product families. Clinical Evaluation Reports were conducted for three product families to help the client better determine their new MDR classification.

Quality Management System (QMS)

The client’s QMS was investigated by RCA’s medical device consultants to confirm alignment between the quality manual and existing standard operating procedures. The documentation had been located in many places and lacked the efficiency of a culture of quality.

Change Control

RCA increased the efficiency of the client’s documentation process so a single hub of information was available for future assessments or audits. A change control process was were implemented to improve how revisions of SOP’s and quality records followed the updated MDR regulations. 

Results

The client’s EU MDR submission for the three product families was successfully delivered on time. The client was able to continue their business as normal operating conditions in each global market.

Packaging Validation

Packaging validation was also optimized based on improved procedures that met the new MDR regulatory guidelines. Supply chain partners and suppliers were educated on the client’s new requirements for optimized validation protocols.

Portfolio Analysis

Finally, RCA helped the client identify additional opportunities to optimize their QMS and portfolio decision analysis based on the new regulatory environment. This led to a portfolio analysis of where expansion opportunities may exist based on the current certification approval.

Client Takeaways

  • Technical file for EU MDR submission was optimized including generation or updates for every element of the file.
  • The client is now moving toward ISO certification
  • One of the client’s suppliers was impressed with RCA in working with our team. This led to additional assessment projects with vendors in the client’s model.
  • The client enjoyed working with the entire RCA team and vendors who were a part of the process have now engaged RCA to help their organization.

 

About RCA’s MDR Consulting Services

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

Our team of over 500 industry experts — including former EU regulatory officials and other 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. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

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 we do not implement good IoT cybersecurity and global cybersecurity protocols. At Regulatory Compliance Associates Inc.®, 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, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the EU, 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 EU veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

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

 

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 EU finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 EU consultant veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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 RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and EU regulatory veterans are fully equipped to handle your unique QA needs.

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

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

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 unique expertise and experience that makes partnering with RCA® Inc. 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® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and MDR consulting 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
  • Product Complaints
  • Medical Information

 

About RCA

medical device consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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 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

 

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

Client

Global medical device organization based in USA in need of EU MDR support. 

Project Timeline

Regulatory Documentation – 4 weeks

Clinical Evaluation Report – 6 weeks

EU MDR Submission – 4 months

Client Challenge

A global medical device firm needed to meet the regulatory EU MDR compliance deadline. Collecting the reference documentation from suppliers was a challenge based on localities. Based on the new CE mark regulatory articles, the client moved from a self-submission regulatory status to a Class 1 device, and the new regulatory information was needed.

RCA Approach

Preparation and consulting time was spent with the client’s leadership team to create a cohesive strategy based on the new EU MDR regulatory environment.

Regulatory Strategy

Training meetings were conducted between RCA life science consultants and the client to explain the new changes from MDD and MDR, and what path to regulatory compliance was needed. The current state assessment involved the Design History File and the current state of QMS.

Standard Operating Procedure (SOP)

A Project Plan was developed that outlined the development or revision of 12 Standard Operating Procedures, and development of complete design history files for 3 current/legacy product families. Clinical Evaluation Reports were conducted for three product families to help the client better determine their new MDR classification.

Quality Management System (QMS)

The client’s QMS was investigated by RCA’s medical device consultants to confirm alignment between the quality manual and existing standard operating procedures. The documentation had been located in many places and lacked the efficiency of a culture of quality.

Change Control

RCA increased the efficiency of the client’s documentation process so a single hub of information was available for future assessments or audits. A change control process was were implemented to improve how revisions of SOP’s and quality records followed the updated MDR regulations. 

Results

The client’s EU MDR submission for the three product families was successfully delivered on time. The client was able to continue their business as normal operating conditions in each global market.

Packaging Validation

Packaging validation was also optimized based on improved procedures that met the new MDR regulatory guidelines. Supply chain partners and suppliers were educated on the client’s new requirements for optimized validation protocols.

Portfolio Analysis

Finally, RCA helped the client identify additional opportunities to optimize their QMS and portfolio decision analysis based on the new regulatory environment. This led to a portfolio analysis of where expansion opportunities may exist based on the current certification approval.

Client Takeaways

  • Technical file for EU MDR submission was optimized including generation or updates for every element of the file.
  • The client is now moving toward ISO certification
  • One of the client’s suppliers was impressed with RCA in working with our team. This led to additional assessment projects with vendors in the client’s model.
  • The client enjoyed working with the entire RCA team and vendors who were a part of the process have now engaged RCA to help their organization.

 

About RCA’s MDR Consulting Services

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

Our team of over 500 industry experts — including former EU regulatory officials and other 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. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

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 we do not implement good IoT cybersecurity and global cybersecurity protocols. At Regulatory Compliance Associates Inc.®, 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, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the EU, 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 EU veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

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

 

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 EU finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 EU consultant veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

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

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts 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 RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and EU regulatory veterans are fully equipped to handle your unique QA needs.

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

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

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 unique expertise and experience that makes partnering with RCA® Inc. 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® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and MDR consulting 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
  • Product Complaints
  • Medical Information

 

About RCA

medical device consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory 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 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

 

To begin the RCA® 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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