Policies & Regulations
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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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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……
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2021.08.05
Mitigating Risk Through Quality Management in Medical Device Manufacturing
Consider these 4 steps when developing a quality management strategy…….
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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……
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2021.06.21
An Ingredient List for Your Medical Device?
FDA seeks feedback on medical device content labeling……
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