Adding value through gap analysis

Bringing in a regulatory consultant from the start can save you a lot of time and money down the line. But many manufacturers aren’t aware of this, and reach out when they’re a part way through the process. More often than not, by that point they’re overwhelmed by the intricacies of the compliance burden. 

By coming in and making a thorough assessment of your processes and product, our consultants can give you an accurate snapshot of your MDR readiness. That means we may ask you important questions about:

• your medical device product
• your Quality Management System (QMS)
• your level of compliance to (certified) standards (ISO) 

Our work usually begins by uncovering what’s not working, and understanding why meeting the requirements of the MDR has become an issue or hurdle. This can be for any number – or any combination – of reasons, including insufficient dedicated resources, a lack of in-house expertise or experience, or simply not enough oversight or capacity to fulfill the requirements. 

The complexity of the MDR means that offering a ‘one-size-fits-all’ solution for companies in this situation would be both misleading and ineffectual. Instead, we personalize our consultancy services for each and every client. And that starts with listening – understanding your pain points, discussing your challenges, and performing a gap analysis.

We find that performing a gap analysis has two practical benefits: identifying areas of strength, and uncovering areas where improvements are needed. This approach surfaces opportunities to fill knowledge gaps with bespoke training, so we can leave your organization better informed and better equipped than when we found you.  

Deeper insights into your company

Getting answers to questions about a particular aspect of the MDR is one thing. But meaningful consultancy that leaves your organization stronger and more resilient going forward offers much better value. After all, a situation where the same questions and same mistakes occur time and time again is unproductive, unwanted, and unnecessary. 

In our experience, medical device manufacturers rarely have just one question. Usually, their most pressing question is the tip of an iceberg. Of course, our consultants will willingly answer any questions you have about the MDR, but doing that on an ad-hoc basis provides little or no value in the long term. It’s a short-lived fix. What works better is a longer term partnership, where we can support you to confidently take the next steps on your compliance journey. 

Building a deeper relationship with your organization enables us to tailor our guidance and support to meet your specific needs. This more personalized approach to consultancy means we’re not simply waving a magic wand and conjuring up a generic one-size-fits-all solution for regulatory compliance (because there isn’t one). 

What you get is a pair of expert eyes over your resources and knowledge – both to validate your internal expertise and identify any blind spots. For example, it could be that your Quality Manager has the right level of expertise, but the way in which the organization is set up – or its culture – is creating barriers to certification under the MDR.

Taking a more personalized approach also means we can advise you on choosing the right Notified Body and route to conformity, so you can maximize the chances of getting a good fit, and establish a positive long-term partnership that works for both your company and its product. 

The impact on organizational structure

Compliance with the MDR has a real bearing on the way an organization is structured. Every company is different, so we take a personalized approach to working with you. One of the key factors is organizational size. This has a strong impact on how you're set up to manage the regulatory burden. 

Generally speaking, in smaller companies, there are fewer people covering more roles as part of their daily duties. Defining who does what in relation to quality management and regulatory compliance can be challenging. In larger organizations, roles and responsibilities tend to be more clearly defined. But this, in itself, can lead to other issues, including a broader lack of understanding about a specific product.

There are two key questions to ask of any medical device: does it perform? Is it safe? The intended users, the intended medical use, and the risk class of the device all have a bearing on how it must be developed, tested, documented, and monitored in line with the MDR. Even for larger companies, this can be hard to get right. 

Like many other types of product, medical devices also have highly-complex supply chains. It can be difficult to know where responsibility lies for making changes, and the extent to which quality and regulatory representatives are involved (or not). 

Balance market value with regulatory controls

Certification and compliance with the MDR doesn’t end with a stamp of approval from the Notified Body, it’s an ongoing process. As consultants, we can help you get your product(s), your documentation and processes certification-ready, but the next ongoing challenge is how to keep up with your regulatory commitments whilst remaining innovative and expanding market value.  

Medical device companies not only have to take full ownership of their product design, they also need to safeguard its use by clearly defining who it’s for, its intended purpose, and the potential risks. Product innovation can sometimes be restricted by regulatory requirements. The key is to retain and grow market value whilst remaining compliant. We know how to do this in a pragmatic way that fits you and your organization.  

Putting your trust in the consulting excellence of Peercode Regulatory Consultancy is a guaranteed way to develop your in-house expertise and abilities and ensures ongoing regulatory compliance with legislation such as the EU’s MDR.

Looking for expert guidance and support for your MDR certification efforts? Discover consulting excellence from Peercode Regulatory Consultancy.

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