Inside one mid-size medtech company, lean teams are dedicated to the development of critical medical devices. For this BDN client, the focus is on Class III medical devices often used to support patients who are facing degenerative diseases, recovering from trauma, or returning to form after sports injuries.
With internal teams dedicated to these life-altering projects, no group had the bandwidth, or necessary expertise, to take on a required company project: EU MDR Compliance.
EU MDR Compliance
Compliance with the new European Medical Device Regulation is mandatory for medical device companies selling their products in Europe. The changes require a significant investment of time and resources to comply with updates to the traceability and safety management of medical devices sold in the EU. While compliance deadlines have been delayed, organizations are investing now to stay on target.
In fact, large manufacturers are dedicating up to 25% of their employees to bring their procedures up to standard. Small and medium-sized manufacturers often lack the internal resources to support such an initiative and look for outside support.
For this particular client, its challenges are similar to others in its industry: looming deadlines, strict regulations, teams spread across multiple locations, and the complications of working during a global pandemic.
Facing these hurdles, this client turned to BDN to oversee its entire EU MDR compliance project. We established a team of 11 consultants dedicated to this organization's program and expect to scale the size of the team as the work expands during this multi-year engagement.
A regulatory program of this magnitude is where Black Diamond Networks has significant expertise, creating entire EU MDR programs for clients, sourcing niche experts and filling roles from executive level through execution across quality, regulatory, and clinical teams.
There is no room for error in regulated industries, which is why BDN clients rely on us to find the high-quality, vetted consultants who can deliver on time, the first time.
One Relationship at a Time
Our success is defined by our close working relationships with our clients and consultants. By listening to what our clients need and understanding the intricacies of each project, we work together to address their challenges and take away many of the headaches associated with complex projects like EU MDR compliance. By partnering throughout the onboarding process and the duration of each project, we can set expectations from day one and work as a team through the successful completion of each project.