Dedicated to design & manufacturing for medical device
25-27 September 2019 | Shanghai,China
Policies & Regulations
2019.04.19 FDA Flips the Switch on Pelvic Mesh Manufacturers FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction. Read More
2019.04.18 Dirty Scopes Are Still a Big Problem FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing. Read More
2019.03.26 Taking a Deeper Look at Device Certification and Recertification Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe. Read More
2019.03.22 Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements. Read More
2019.03.14 SO 80369: Frequently Asked Questions, Answered Here are answers to some common questions about developing and testing small-bore connectors. Read More
2019.02.25 8 Things You Should Know about the EU MDRs Respondents to a recent survey on the new EU regulation raise some concerns about readiness. Are you prepared? 阅读更多
2019.02.22 Considering Old and New 510(k) Predicates span style="font-weight:normal;">Is a new device necessarily better? 阅读更多
2019.02.19 Another Reason to Update Your Biocompatibility Approach: EU MDRs A chemist and biocompatibility expert offers the latest insights and predictions on medtech biocompatibility testing. Read More
2019.01.23 How Is the Government Shutdown Impacting Medtech? FDA cannot accept new 2019 user fees during the government shutdown, which means the agency cannot accept new medical product applications. Read More
2018.12.27 Essure Discontinuation Doesn't Mean the End to FDA Scrutiny Bayer has already decided to stop selling the controversial birth control device, but FDA says it will continue to monitor the long-term safety of Essure. Read More