What to Look for in a Medical Device Quality and Regulatory Compliance Consulting Partner: The Definitive Checklist

Author: Anne Holland, CEO and Founder

You know the drill. You’re tasked with identifying and selecting a medical device quality and regulatory compliance consulting partner. Once the initial panic wears off, you start searching for companies that can help navigate the complex environment. Throughout the process, you long for a roadmap or checklist of the most critical factors to look for in choosing the right partner.

I’ve been there, and during my 20-plus year career, I’ve learned what it takes to build a beneficial client-consultant relationship.

At the center of your decision, you’re trying to find a medical device consulting partner to analyze your business objectives and requirements to develop pragmatic, disciplined quality systems and strategies, with clear and concise documentation – without losing sight of innovation.

But how do you assess if the firms you are researching can do this?

Here are the top five criteria I’ve identified as crucial to selecting the right medical device quality and regulatory compliance consulting firm.

1) Certifications and Credentials – When selecting a medical device partner, check to see if the company is certified and that its employees are credentialed based on industry standards. In our industry, work with a firm that is ISO 13485 certified, the standard for quality management systems in the medical device industry. Further, confirm that the individuals you’d be working with are ASQ Certified Quality Auditors, Exemplar Global Lead Auditors, or hold other relevant certifications. Looking for these credentials when choosing a partner gives you the peace of mind that you’re working with a team of experts who provide the required independent and objective third-party for quality systems audits.

2) Experience and Expertise – Finding a consulting partner with real-world experience, a diverse background, and who understands the medical device quality and regulatory compliance landscape is critical to a successful relationship. I believe the strongest partners apply a team-based approach to their services. This ensures you receive the maximum benefit from them. You want to look for a team who has dedicated their careers to this profession because they bring a depth and breadth of expertise in key areas. Look for nationally recognized and highly-accomplished consultants with deep expertise in risk management, process validation, internal and supplier audits, regulatory strategies (with submission and registration) for the FDA, and microbiological services. You should also seek a firm with various experience levels to ensure you’re paying for (and only for) the skills you need.

3) Cultural Fit – Hiring the right medical device consulting partner is as important as hiring a new employee. Therefore, as you would interview a candidate for a position at your company, it is essential to do the same for a consulting partner, including asking questions about their values. Nothing is worse than realizing - after the contract is signed - that the personalities of your company don’t align. Having shared values builds the type of partnership that allows quality and regulatory compliance to be integrated throughout the product lifecycle and across every aspect of your business.

4) Internal Document Control Processes – You can be certain of one thing: the medical device landscape is fast-paced and constantly evolving. Keeping up with all of these changes can be overwhelming. Your job is to choose the right partner. The consultant’s job is to maintain cutting-edge knowledge of current and impending FDA regulations, industry trends, and build these into their processes. Look for a consulting firm that holds its internal processes to the highest standards and takes a disciplined approach to placing quality and regulatory compliance controls where they are needed. Such controls will help verify and validate that requirements have been achieved and should include documentation to support each step in the process, giving you the confidence that all possible measures have been taken to exceed industry standards. Overlooking the fundamentals could result in a lack of compliance, delayed approvals, and potential revenue loss.

5) Innovation and Creativity – When you assess fit, ask yourself, do you want a ‘one-size-fits-all’ partner or a partner who, while adhering to standards, tailors an original solution to meet your business objectives? I have found the most productive business relationships are those where a consultant invests the time to understand your objectives, learn your needs, and then tailor a solution custom-fit to accomplish your goals. Look for a medical device consulting partner whose core values include delivering comprehensive, personalized services, and unparalleled client service.

At QA Consulting, we pride ourselves on expressing our values in all that we do, and partner with clients who take a similar approach to ensure integrity, safety, and effectiveness. Our top-notch team of experts manages client projects using the FDA and QMS ISO 13485 certified frameworks.

When it comes to realizing the potential of your medical device in today’s complex and ever-changing market, seek a consulting partner who inspires you to think about quality in every aspect of your business as a mindset for future success – you won’t regret it!

Lean into quality with medical device systems everyone can trust. Contact us today to learn how our quality and compliance know-how can help you meet your business goals.


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