How to Register Your Device in Australia
This article provides a high-level view of how a company can enter the Australian market and leverage their CE Marking...
Jul 13 2016,
Regulations
3 Points to Consider from the Long-Awaited EU Medical Device Regulations
The new EU Medical Device Regulations could make it tougher for orthopaedic device manufacturers to do business in Europe. ...
Jul 11 2016,
Third Party Reviews – Is This the Real Deal?
Companies with simpler products like arthroscopes and surgical instruments could consider a regulatory route that doesn't start with FDA and...
Jun 23 2016,
Trade Secrets Go Federal
Passage of the "Defend Trade Secrets Act" (DTSA) federalized the trade secret law. One of the key aspects of DTSA...
Jun 23 2016,
Invibio Settles FTC Antitrust Allegations Concerning PEEK Market
Invibio, the first company to sell implant-grade polyetheretherketone or PEEK, agreed to settle Federal Trade Commission (FTC) charges that it...
May 25 2016,
FDA Issues Draft Guidance on Additive Manufactured Devices
FDA published draft guidance on technical considerations for additive manufactured devices in response to the technology’s advancements and investments. Among...
May 24 2016,
Supplier Quality Agreements Are Not Just a Handshake Anymore
Regulatory bodies do not see supplier quality agreements as a new requirement. They also expect medical device manufacturers to require...
Apr 22 2016,
FDA Releases UDI Education as Deadline Approaches
FDA released a series of resources to help companies understand GUDID submission, UDI labelling regulations and compliance schedules. The resources...
Apr 12 2016,
FDA Releases Final Guidance on Human Factors and Usability Engineering
The Agency released the final guidance on considerations for human factors data in premarket submissions, as well as two draft...
Apr 12 2016,
Proving Medical Necessity: the Need for Evidence in Reimbursement
Providers, OEMs and suppliers all say that they’ve been impacted by complexities in the reimbursement system. For example, bundled payments...
Mar 23 2016,
New Guidance for UHMWPE Submissions
FDA recently released draft guidance outlining new information companies must include when submitting devices with Ultra High Molecular Weight Polyethylene...
Feb 23 2016,
The Revitalized ISO 13485: Ready for Business
The ISO 13485:2016 Standard is slated for publication in March 2016. Consider these eight changes when updating your certification. The...
Feb 08 2016,
A Look at FDA’s 2016 Priorities, Status of 2015 Priorities
FDA released its annual priority list for the new year, as well as previously-issued final guidance documents, on which CDRH...
Jan 12 2016,
UDI Update: Trays and Kits
FDA released draft guidance for its Convenience Kit exemption, offering orthopaedic device manufacturers more direction on labeling device trays and...
Jan 11 2016,
Congress Suspends Medical Device Tax
The medical device tax, fought by industry since its inception, was suspended as part of the $1.8 trillion spending and...
Jan 04 2016,