×

Biocompatibility

hip joints

Test or Evaluate? Biocompatibility and Orthopaedic materials

By Arthur Brandwood | 06.03.2019
This morning, the US FDA announced with a tweet, the publication of a new guidance on Ultra High Molecular Weight Polyethylene (UHMWPE) in Orthopaedic devices. "Manufacturers should include test data...
Align

FDA and ISO stars aligning on ISO 10993

By Dave Spicer | 10.18.2018
Download presentation slides
Ventilator patient

Biocompatibility of Breathing Gas Pathways

By Arthur Brandwood | 08.05.2018
ISO 10993-1 requires that devices which contact the body indirectly - by means of a fluid or gas passed through the device and into the patient - must be assessed...

Search

Recent Posts

Australian TGA To Introduce AusUDI

Aug 19, 2019

Cybersecurity – Is Your Device Software Secure?

Aug 13, 2019

Inaugural Course on Molecular Toxicology

Aug 5, 2019

Beyond a business merger, diverse skills come together at Brandwood CKC

Aug 5, 2019

Applications Closing Soon – November PL.

Aug 1, 2019

Importance of Innovation

Jul 29, 2019

Categories

Categories

Archives

Archives

Archives

Tags

3D 3D printing 510(k) 510(k) PMA adverse events Apple Watch Artificial Intelligence Australia Biocompatibility Biomechanics Brexit CE CE Certificates CFDA China clinical evidence distribution Europe FDA Health Canada IVD IVDR MDR MDSAP mechanical properties medical device medical devices New Zealand Notified Bodies PMA PMDA post market postmarket premarket Quality Systems Reform regulatory Reimbursement SaMD Software standards Sterilisation TGA UDI Webinar
Translate »