A proven partner with experience and expertise

Peercode is currently a legal manufacturer for three Software as a Medical Device (SaMD) products. That means the people at Peercode have firsthand experience of the medtech market – particularly in navigating the EU’s MDR. Apart from the MDR, we know our way around the complete regulatory landscape – just see our blog on navigating the labyrinth of legislation in the medtech world.

Couple that with the clients we’ve supported to gain access to medtech markets around the world, and you’re looking at a regulatory compliance partner who’s walked the road you’re on many times before. For example, we know you’re up against an extensive timeline. It’s not just a case of updating a Notified Body and the next day something happens. The road toward certification is a long one and full of pitfalls that can delay your time to market.

Cost is another factor. Many companies underestimate the cost – in terms of time and money – of getting compliance right. It’s also not a one-off activity. Regulatory compliance for medical device companies is an ongoing responsibility, including quality and risk management, change management, and Post-Market Surveillance (PMS). To help you budget, we can help you understand the upfront costs and ongoing operating expenses associated with regulatory compliance across different global markets. 

For medical device manufacturers, regulatory compliance is an essential component of product development. Rather than produce a finished product and then afterward check if it fits with the requirements, product development should evolve hand-in-hand with relevant regulatory guidance. Otherwise, you might waste time and money on developing a product that doesn’t fit the requirements. Don’t leave it until the end of your research and development to discover whether your product is market-ready. 

No need to reinvent the regulatory compliance wheel 

The benefit of having driven this road many times before is that we can share our regulatory knowledge and expertise with you. In fact, giving regulatory advice is something we love to do. Put it this way. The wheel of regulatory compliance has already been invented. The compliance vehicle and all its mechanisms are engineered. What we do is help you start the engine, and teach you how to drive it. 

At the same time, bringing in an expert partner takes the heat off your involvement with regulatory compliance, enabling you to focus on core activities like running your business, or product development. Compliance for medical devices also requires cultural change within your organization. Company culture needs to align with regulatory guidance, so that everyone knows what can and cannot be done. 

Change management in a SaMD is a great example. Each developer needs to know that they cannot simply push an update. They need to be trained on the restrictions that impact their work, following processes that are MDR or ISO 13485 compliant. This cultural shift takes time, training, and practice. 

Ensuring the correct product classification

Determining the classification and risk class of a medical device is essential. That’s because in some cases, a product thought to be a medical device actually isn’t one – and vice versa. Health-related products – such as fitness trackers – are a great example of this. 

On the other hand, products classified as medical devices also need to be assigned the correct risk class. This is not an easy process, and getting it right is essential for preparing the correct documentation and putting the right Quality Management System (QMS) in place. 

Expertise you need: upskilling, mentoring, and auditing 

Larger medtech companies tend to have in-house expertise in quality management and regulatory compliance. But for everyone else – small and medium-sized enterprises (SMEs) – bringing in a regulatory consultant from Peercode puts them on a level playing field in terms of knowledge and expertise. 

On top of that, our highly-trained consultants can give you the auditing expertise you need.  That’s especially helpful if you’re too small to have an independent quality management team. In fact, knowledge-sharing is an important part of what we do at Peercode Regulatory Consultancy. We’re dedicated to training your internal staff to do the work we do. 

Our approach to regulatory consultancy is very much tailored to our client’s needs. No two medical devices or companies are the same. We take you through the entire end-to-end process, or jump in whenever we are best placed to help. Not only do we add expertise and capacity around regulatory compliance, we also leave your organization better trained and better informed than when we found it.  

With our own MDR-certified SaMDs on the EU market, we’re also a great choice for software companies looking to navigate medical device regulations. On top of that, we’re busy preparing for the EU’s AI Act so we can help SaMD companies with compliance and best practices. Plus, as a company operating in the EU with our own line of software products, we’re also well-positioned to offer advice and guidance on compliance with the General Data Protection Regulation (GDPR). And that’s another Peercode advantage.

To discover more about the advantages of Peercode Regulatory Consultancy for medtech companies, speak to a specialist today