For medical device manufacturers, there are three main partnerships to consider: Notified Bodies, suppliers, and consultancy services. It’s advantageous to ensure a strong match between your product, your organization size, and a Notified Body. 

In the same way, reliable and trustworthy suppliers are essential to the success of your product. The right consultancy partner can help with both of these things and more. However, if you’re not careful, a mismatch between partners can result in lost time, money, and focus.  

Here’s why great partnerships matter to medical device companies like yours. 

Save time and money with a single Notified Body

Choosing the right Notified Body can be a complicated and time-consuming task. Each one has a specific designation based on product risk class and medical area – they don’t certify every type of medical device product. There are many factors to consider when making this choice. Information is available on the EU website (search for ‘NANDO’) but it still takes significant amounts of time to research the right partner. So how can you get it right?

Larger Notified Bodies usually handle a broad range of products, but more niche products require more specialized services. Larger medical device companies with a broad product portfolio need to work with a Notified Body that has an equally broad scope of accreditation, with expertise in multiple areas. Smaller Notified Bodies tend to be more specialist and accessible, and therefore a better fit for smaller medical device companies.

Not only should a Notified Body be correctly accredited for your type of device, it’s also important that they can certify your Quality Management System (QMS). Otherwise, you may end up working with more than one Notified Body. This has a cost implication – double if you’re working with two separate bodies. You’re then in a scenario where you have two partners who are also having to check each other’s work – so you’re also doubling up on time. 

Regulatory consultants can bring you extensive experience of the inner workings of Notified Bodies, which can help your product, processes, and your submission file. They can support you to make the right choices. At Peercode, we’ve worked with multiple clients and Notified Bodies across a range of medical areas. Not only that, we also have first-hand experience of bringing our own software as a medical device (SaMD) products to market. 

Build a reliable supply chain that scales with you

Organizational size is also a key consideration when choosing supply chain partners. If you need to outsource all or part of the manufacturing process, it makes sense to select suppliers of a similar size to your company. That’s because it creates a shared interest in bringing a product to market and making it a success, from which both parties stand to gain. 

When a small medical device company depends on a large-scale supplier, the larger supplier has less of a vested interest in the success of the product because they have other clients who may be potentially more lucrative. 

There also needs to be a quality agreement in place between your company and the supplier to set out expectations for the product or components being purchased. It’s vital to ensure there’s scope to make changes to a product. If the supplier is not able to change with you, then they may not be the best fit. 

A supplier assessment will help with this decision-making. It will document your expectations and requirements, the kind of agreement you need and have, and any risks. Risk is at the heart of all the work you do in this respect, so this is a chance to document the relationship with a supplier and/or a quality contract. You’ll also document why you’ve chosen them as a supplier within your quality system. As different regions have different regulatory requirements for data privacy, it’s worth defining where sensitive product data is stored.  

Collaborate with consultants to create value

Getting support with medical device compliance is vital for medical device companies lacking the relevant, in-house expertise. A good collaboration can leave your organization stronger and more adept at handling regulatory compliance, ensuring you successfully bring medical devices to the market – and keep them there.

In the ideal scenario, the regulatory consultant joins you on a temporary basis, and educates your in-house team. It’s like teaching another person to drive. The relationship is an educational one – at some point, your team will drive away with their own regulatory knowledge. This is especially true of larger organizations. At the same time, smaller medical device companies might choose to retain a consultant in the role of Person Responsible for Regulatory Compliance (PRRC), which is allowed to be an outsourced role. 

To achieve the best outcomes, the consultant should have the correct technical expertise and knowledge of the relevant markets. What begins with the EU market might quickly grow to other territories, such as the US, UK, or Canada. The consultancy should therefore not only have the ability to scale with the company, but also expertise in different global markets – otherwise the relationship is likely to end.  

Cultural and technological fits are also vital for this relationship to thrive. Companies need to feel comfortable sharing systems, sensitive information, and responsibilities to enable consultants to work unhindered and effectively. On both sides of the partnership there has to be enthusiasm, honesty, pragmatism, trust, and transparency.  

At Peercode Regulatory Consultancy, we bring in regulatory knowledge and expertise to your medical device company. Speak to one of our specialists.