Why We Love Improving Lives By Giving Regulatory Advice On Medical Devices

Why We Love Improving Lives By Giving Regulatory Advice On Medical Devices


Regulations are there for a reason. In the medical device sector, they keep patients and medical professionals safe from harm. However, under the weight of regulatory burden, companies need external experts to help put together their technical dossier, and ensure it meets the requirements of the Medical Device Regulation (MDR).

As external advisors on regulatory compliance for medical device companies, our work helps add value for businesses, medical professionals, and patients. Here’s why we love it.

Improving Patient Safety And Outcomes

Although patient safety should be front and center of every new medical device, development costs, and other financial imperatives mean that it can sometimes drift a little out of sight.

No-one wants an unsafe medical device. At the same time, unintended or unforeseen harm to patients due to a faulty device or a malfunction can have serious reputational and financial repercussions for healthcare providers and medical professionals. Proper risk analysis and product verification and validation clear the path for a better and safer product on the market.

What we love about our advisory role is that we can help companies strike the right balance between launching a commercial product and ensuring patient safety. After all, every medical device has the aim of improving patient outcomes in some way.

However, in the rush to get a product to market, details can sometimes get missed. Offering a fresh pair of expert eyes over the technical dossier, we can help spot new or unseen risks – saving both the company and patients from potentially negative consequences. This minimizes the risk of lawsuits and financial penalties being imposed on medical device companies.

Smoothing The Path To Certification

Bringing in one of our experts is a great way to eliminate the fear of getting something wrong in the race for certification by a Notified Body. Time is money, as they say.

Preoccupied with the development of a marketable product, companies can sometimes be fearful of the regulatory burden. There’s so much to account for, and much of it can be difficult to understand. In our capacity as an external expert, we get to make it practical and pragmatic for them.

By educating companies on regulations and processes, we can help take away some of that regulatory fear. In fact, one of the things we love most about our role is we can boost their confidence in getting their documentation to the right standard, ensuring compliance with the relevant regulations.

With a fully compliant medical product backed by a robust quality management system, companies can feel confident in the future safety performance of their product. In turn, they can use that confidence to promote trust in their product from medical professionals and their patients.

Enhancing Products And Processes

What we do also has tangible business benefits – especially for small and medium-sized businesses who are still trying to firm up robust and effective internal processes. Compulsory compliance with the MDR actually creates an opportunity to get a tighter grip on these processes and improve them for the benefit of the business. This includes everything from quality management systems to effective oversight and control of supply chains.

Another thing we love about supporting companies with regulatory compliance is that through education, we’re helping them to independently manage it going forward. In fact, our work acts as an on-ramp for setting up robust internal processes for compliance. Of course, we’re always available to offer technical guidance, but our aim is to see them grow and become fully independent. It’s a bit like teaching someone to drive. We aim to help companies take over the processes required to go it alone.

Sharing The Love

Medical device companies are experts in what they do. But sometimes they don’t necessarily see the bigger picture of regulatory requirements and the structures and processes needed to be compliant.

It’s never a bad thing to get a second pair of eyes on your documentation for MDR compliance. Especially as patient safety is at stake. After all, with so many requirements, it can be a real challenge to successfully implement the technical dossier.

In their quest to support medical device companies with MDR compliance, our experts become invested in their work, conducting independent research and sharing new ideas and knowledge to help companies make better processes and products.

Bringing in a regulatory expert in the early stages helps to ensure that the technical dossier is correctly implemented, improving patient safety, smoothing the path to certification by a Notified Body, and enhancing products and processes.

Need expert advice on the MDR? Speak to one of our specialists, today.