Policies & Regulations
-
2018.07.30
Should Medical Devices Come with Expiration Dates?
Implantable medical devices containing highly sophisticated electronics are lasting longer than before, raising the bar for safety and liability.
Read More -
2018.07.27
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Design History File vs. 510(k) vs. Technical File: What Do Medical Device Developers Need to Know?
Read More -
2018.07.04
Is FDA Getting More Cozy with AI?
FDA’s recent approval of stroke detection software paves the way for Artificial Intelligence applications to thrive on the healthcare landscape.
read more
Read More -
2018.06.11
Get Answers to Your Usability Testing Questions
A live demonstration of formative usability testing at MD&M East aims to share best practices and answer attendee questions.
Read More -
2018.02.01
New EU MDR Regulations and Revamp of the Medical Device Directive
An overview of the key impact points and challenges of European Union Medical Device Regulation.
Read More -
Act Now to Prepare for MDSAP Audits
The clock is ticking for medical device manufacturers worldwide. Manufacturers that want to continue selling products in Canada’s $6.7 billion medical device market should be preparing and planning for the international Medical Device Single Audit Program (MDSAP) by now. Canada is the first market to require the MDSAP audit as part of its medical device licensing scheme, beginning Jan. 1, 2019. On that date, companies selling Class II, III, and IV medical devices and IVDs must have an MDSAP Certificate on file with Health Canada to maintain their Canadian Device Licenses.
Read More -
2018.01.19
FDA releases top 3 medical device regulation goals
FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paperStrategic Priorities paper that FDA’s CDRH released today.
Read More -
2017.07.13
FDA Exempts Over 1000 Devices from 510(k) Requirement
The 21st Century Cures Act paved the way for deregulation of a host of medical devices ranging from surgical lights to dentures.
Read More -
2017.04.28
4 top regulatory issues to watch in 2017
This is shaping up to be a big year when it comes to medtech regulation, as well as regulations for other types of life science companies.
Read More -
2017.04.21
FDA Proposes Ban on Powdered Gloves After Years of Review
In a rare move, FDA has proposed banning most types of powdered medical gloves in the United States. Some say the decision took too long.
Read More