Medical Grade Polyurethanes have been used for years to support the advancement of medical device development. They have been used in devices ranging from short-term disposables to long-term implants. Biomerics has remained at the forefront in providing quality and consistency in the Quadra Family of Medical grade Polyurethanes we manufacture since 1994.
As Biomerics has grown from its beginnings as Utah Plastics Group, quality and consistency remain at the forefront of what we offer.
As the regulatory burden on medical devices has increased over the years, Medical Device Companies need more than ever suppliers that provide materials under stringent quality guidelines to ensure their devices’ regulatory success. Currently, only a few companies have robust Quality Management systems in place to track all aspects of Medical Grade Polyurethane manufacturing, including raw materials traceability, processing controls, documentation, etc.
However, the last few years have seen various requalification activities that have caused Medical Device Companies to assess risk differently than they did years ago. Facility moves and raw supply requalification activities have forced Medical Device companies to devote countless hours and dollars to accommodate these activities. To make issues even worse, some Medical Grade Polyurethane manufacturers have not provided adequate support, notice, or safety stock to support Medical Device companies through the requalification process. In some cases, this has caused products using those Polyurethanes to slow or halt.
Biomerics’ approach to requalification activities has always been proactive as opposed to reactive. Beginning in 2017, Biomerics had gone through several activities to ensure our customers are notified of a change adequately and timely (including the chance to secure additional safety stock before a change) and offered a full requalification report of every requalification activity we perform.
Biomerics commits urgency and speed as well and pledges to complete activities as fast as possible.
Our team also provides ongoing support to Medical Device Companies throughout the various documentation and regulatory questions our customers encounter to ensure a smooth transition.
Biomerics’ commitment to Quality ensures that all our materials have the appropriate level of documentation and traceability to meet Medical Device approvals’ regulatory challenges. Further, Biomerics has taken extra risk mitigation steps of eliminating raw material sole source situations across the Quadra Family of Medical Grade Polyurethanes.
If you are having challenges with Medical Grade Polyurethane requalification, please give us a call to see how Biomerics can help secure long-term stability in your Medical Grade Polyurethane Supply Chain!
Commercial Director, Materials and Compounding