Compliance Audit Consulting

 

Today’s medical device companies face more pressure than ever to meet the increasing and evolving demands of an internal audit. Many businesses are implementing a risk assessment internal audit to identify insufficiencies, evaluate risks, and determine inspection readiness. These strategies smooth the regulatory compliance audit process and provide a greater chance of FDA audit success.

 

Conducting periodic internal audits is one way that many companies choose to ensure compliance with ISO standards, cGMPs and international regulations. At Regulatory Compliance Associates^®, we have healthcare compliance audit expertise with both short, targeted internal audits and more substantial assessments across the quality management system. No matter what your goals are, RCA’s regulatory audits team will teach you how to prepare for an FDA audit & increase FDA inspection preparedness.

 

Internal Audit Services

 

Using an RCA audit risk-based strategy, Regulatory Compliance Associates^® will help your company identify and correct compliance deficiencies and choose the best regulatory compliance audits for FDA inspection readiness.

 

ASQ-CQA or Exemplar Global certified auditors are available for the following medical device audits:

 

• Current Good Manufacturing Practices (cGMP) Compliance Audits:
  • Manufacturing, Pilot Plant, Laboratory Facilities
  • CAPA Audit
    • FDA Audit Preparation
    • FDA Audit Training
    • FDA Audit Support
• Current Good Laboratory Practices (cGLP) / cGMP Compliance Audits
• Regulatory Gap Analyses
  • Pre-Approval Audits
  • CFR Part 11 Gap Analysis
  • Risk Assessments
  • FDA Audit 483 Observations
• Quality Systems
  • 21 CFR 820 Audit
  • ISO 13485 Audit
  • Development of Inspection Checklists
• Internal Audits
  • Contract Manufacturer Audits
  • Supplier Audits
  • Scribe Audit
  • Virtual audit
• Medical Device Single Audit Program (MDSAP)
  • MDSAP Compliance Audit Readiness

 

The RCA Advantage

 

Compliance gaps can sometimes blindside even the most prepared medical device companies during agency inspections. Teaming with Regulatory Compliance Associates^® ensures you’ll be as prepared as possible to face FDA audit questions.

 

As an industry-leading risk assessment consultant, we offer a host of compliance audit services:

 

• Our staff are seasoned audit experts — many have decades of experience working with the FDA and preparing for FDA inspections.
• We understand audit preparedness — RCA’s compliance consulting team has in-depth knowledge of FDA regulations for medical devices so that you know exactly how to plan for your FDA inspection.
• We not only offer healthcare audit services, but we also have the processes in place to help you make sense of findings and manage the corrective action process.
• Not only does our audit scribe team monitor problems that regulatory agencies are likely to uncover, but we also consider the big picture to ensure the compliance of your quality management system.

 

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 consultant 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 medical device consulting companies 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 medical device regulatory 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 consultants & 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.

 

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

 

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 medical device consultant assistance 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

 

Remediation Services

 

Regulatory Compliance Associates^® is widely recognized within medical device consulting companies & the life science industry for remediation service & support. Regulatory Compliance Associates^® ability to help companies successfully resolve complex regulatory challenges has 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.

 

Our compliance audit 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 
• Quality Metrics

 

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
• Product Complaints
• Medical Information
• Compliance Audit
• Risk Management Plan

 

About Regulatory Compliance Associates

 

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

 

• Life Sciences
• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

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 5,000+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 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.