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December 7-9 2022 | Suzhou lnternational Expo Centre B1-E1
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Policies & Regulations
2022.08.15 State-of-the-Art:Unpacking MDR’s Evolving Requirements Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and clinical data may allow a clearer understanding of regulatory expectations to emerge....... Read More
2022.08.04 FDA eases UDI compliance requirements for some low-risk medical devices The U.S. Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles...... Read More
2022.07.13 Would the New CMS Rule Harm Medtech? Centers for Medicare and Medicaid Services (CMS) unveiled its 2023 payment proposal. Here's how it would impact some medical device companies and sectors...... Read More
Centers for Medicare and Medicaid Services (CMS) unveiled its 2023 payment proposal. Here's how it would impact some medical device companies and sectors...... Read More
2022.06.27 A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices? Based on ISO 10993-18, some medical device manufacturers to wonder if an extractables study is required for all devices, regardless of duration of contact. Experts at Nelson Labs share their knowledge on the matter...... Read More
2022.05.31 In Vitro Diagnostic Medical Devices Regulation Takes Effect The deadline impacts new devices but amended regulation grants most IVDs (depending on their risk class) three to five more years to comply...... Read More
2022.05.23 Exploring Valve Technology Requirements Under the New MDR Among the many standards and regulations affecting the medical device industry is the European Parliament (EU) 2017/745 standard, also known as the Medical Device Regulation...... Read More
2022.04.28 Moody’s warns of cybersecurity, antitrust and supplier risks for medical device companies Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s....... Read More
2022.04.22 Assessment of Medical Devices Without Animal Experiments To ensure patient safety, regulations such as the EU Medical Device Regulation require risk assessments to be conducted for all medical devices, including biological evaluation in accordance with ISO 10993. This article explores how manufacturers can have their products assessed efficiently without animal experiments...... Read More
To ensure patient safety, regulations such as the EU Medical Device Regulation require risk assessments to be conducted for all medical devices, including biological evaluation in accordance with ISO 10993. This article explores how manufacturers can have their products assessed efficiently without animal experiments...... Read More
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
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