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. 

Companies entering a medtech market for the first time – or even those transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) – face a mountain of regulatory compliance. Whether you’re two people in a room, or tens of people on an office floor, resources can quickly become thin. The fact is, people in smaller organizations often have to fulfill multiple roles. 

Now add the burden of regulatory compliance into that mix. Who in your organization has the time, expertise, and strategic know-how to get it done? There’s no quick fix, but wouldn’t it be great to lean on a regulatory expert? A trusted partner who’s walked the same road before, and even has its own medtech products on the market. That’s the advantage of regulatory consultancy from Peercode. 

Medical devices have a direct impact on people’s health and the quality of care they receive from healthcare providers. For that reason, the medtech industry is tightly wrapped in regulation, and a product’s quality and correct usage are paramount. 

Legislation like the EU’s Medical Device Regulation (MDR) is there to enforce consistent and stringent standards for all. But, for medtech companies bringing products to multiple markets, it adds to a labyrinth of legislation. Here are our expert tips for navigating it.