Policies & Regulations
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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……
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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……
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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……
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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……
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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……
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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……
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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……
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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……
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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……
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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?……
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