Dedicated to design & manufacturing for medical device
August 31-September 2 2022 | SWEECC H1&H2
EN | 中文
Policies & Regulations
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
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