中国国际医疗器械设计与制造技术展览会(Medtec China)2021

Dedicated to design & manufacturing for medical device

August 31-September 2 2022 | SWEECC H1&H2

Policies & Regulations

2022.01.25
Extended Transitional Provisions for EU’s IVDR Expected Rather than a Delay

Revisions to the IVDR’s transitional provisions may grant some IVD manufacturers extra time for compliance, but there is much work to do......



Read More

2022.01.10
Medtronic Recalls Synergy Cranial and Related Software Due to Glitch
Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the risk of potential inaccuracies......



Read More

2021.12.31
Risk Management Means So Much More than EU Medical Device Regulation Compliance
Medical device companies can employ risk management for better project execution, better clinical and field experiences, and improved profitability, says product development expert Perry Parendo......



Read More

2021.11.12
Is Integra's Breast Reconstruction PMA Doomed?
Despite getting shot down by a recent FDA advisory panel, Integra's management team still seems confident that the agency will ultimately approve SurgiMend for post-mastectomy breast reconstruction......



Read More

2021.11.04
Localizing Medical Device Content for Global Markets
Is linguistic quality assurance a necessary requirement or an additional bottleneck for medical device companies?......



Read More

2021.09.13
Changing Medical Device Regulations in the United Kingdom and in Europe
A look at how medical device companies can meet the need for a UK Responsible Person......



Read More

2021.08.05
Mitigating Risk Through Quality Management in Medical Device Manufacturing
Consider these 4 steps when developing a quality management strategy.......



Read More

2021.07.27
Secure by Design: Developing Cybersecure Medical Devices
As software-based medical devices become increasingly connected, cybersecurity must be considered right from the first design stages in order to protect patients’ health and personal data. However, in many instances there are no standards or clear guidelines for the medical sector......



Read More

2021.06.21
An Ingredient List for Your Medical Device?
FDA seeks feedback on medical device content labeling......



Read More

2021.05.19
One Year After EU MDR Delay, Plenty of Barriers to Compliance Remain
Manufacturers continue to face a lack of clarity, high costs, and manual processes in order to comply with the new medical device regulation (EU MDR), according to a recent survey. These results come one year after the regulation’s postponement and a few weeks before the new validity date......
Read More

Page 1 of 7 (67): 1 2 3 4 5 6 7