How does HIPAA affect medical devices?
Medical device manufacturers need to understand patient privacy law and how to comply with it…….
How major medtech companies are responding to the looming EU MDR
Medtech companies that sell products in the European Union have a major deadline looming — one that’s already been put off once…….
How plasma treatment offers green, cost-efficient preparation of plastics
Surface treatment to prepare medical device components for printing or bonding may require complex cleaning methods or harmful chemicals. Plasma etching for improved adhesion, once limited to low-pressure chambers, is now available at atmospheric pressure…….
Is this the next generation of orthopedic device outsourcing?
Major orthopedic device companies appear to be shifting the entire manufacturing and sourcing of certain products to their suppliers. Orchid Orthopedic Solutions is positioning itself to be in the vanguard of orthopedic device outsourcing…….
What will pandemic disruptions mean for EU IVDR?
Certification under the old EU In Vitro Diagnostic Directive (IVDD) cannot be grandfathered into IVDR. IVD manufacturers must start prioritizing product portfolios and conducting gap assessments now to ensure compliance by the May 2022 deadline…….
6 ways the right tubing supplier can improve product development
Partnering with a vertically integrated manufacturer can help engineers optimize designs, improve manufacturability and accelerate new product development…….
Building a Better Supply Chain Through Unique Device Identification
Class I medical device companies have work to do, despite the UDI enforcement delay…….
EU MDR Approval: Performing the Literature Search
Under the new regulation, medtech manufacturers can no longer defend their claims with limited clinical data; the depth, breadth and scrutiny on clinical data is much more rigorous…….
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Name That Medical Device; a Guide to Medical Device Branding
What’s in a name? More than you might think. An expert in healthcare branding reveals trends and opportunities in medical device branding. ……
Laser Solutions for Device Cutting from Tubes and Flat Stock
Two medical device manufacturing companies share their experiences with specialty laser-cutting machines…….
