Even a cursory glance at the EU’s Medical Device Regulation (MDR) – over 170 pages, more than 100 articles, plus 17 annexes – tells you one thing: there are no quick-fixes when it comes to regulatory compliance for medical devices. 

To avoid the hassle, delays, and ongoing back and forth with a Notified Body, many medical device manufacturers seek external expertise on regulatory compliance. That’s because getting the Quality Systems Requirements (QSR) and the product documentation right first time enables them to bring their medical device to market, faster and more easily.

This is why many medical device companies turn to consultants who possess both regulatory expertise and the ability to take a personalized approach to compliance. In other words, they seek consulting excellence that fits their organization and product.

Any medical device destined for the EU market needs a technical file. And if you’ve been following our blog, you know that a vast amount of documentation is needed to get a product certified under the Medical Device Regulation (MDR). That documentation must also be accurate, and structured in the right way.

Whether you’re a newcomer to the medical device market or part of a seasoned medtech team releasing a new type of product, knowing what you need to include, and how to get started with your technical file isn’t easy. That’s why you need a roadmap for compliance.      

Get regulatory compliance right for your medical device product, and you benefit from a smoother path to certification, a speedier time to market, and a strong competitive advantage. But get it wrong, and you’re staring at a mountain of costs in terms of time, money, and human resources. 

At best, getting it wrong can delay a product on its journey to market. At worst, it could lead to product recall or to not entering or removal from the market, not to mention lasting damage to your company's brand’s reputation. Either way, the cost of quality is lower than the cost of noncompliance. That’s why it pays to get compliance right first time.