Regulatory

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U.S. FDA Introduces Safer Technologies Program to Promote Safe, Early Access to Innovative Medical Devices

Published: January 12, 2021

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New Guidance: Classification of IVD under the IVDR

Published: November 24, 2020

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Preparing for a Pre-Submission Meeting En Route to Regulatory Approval

Published: November 3, 2020

Scientist points at mass spectrometry analysis on a computer screen in a lab representing NAMSA's extractables and leachables testing capabilities using chemical characterization

Preparing Biocompatibility Risk Assessments for International Registration

Published: October 26, 2020

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FDA Releases New Draft Guidance for Biocompatibility of Devices in Contact with Intact Skin

Published: October 19, 2020

Responding to Regulatory Requests for Additional Information

Published: October 16, 2020

Scientist in lab attire using a pipette with blue lab equipment in view representing NAMSA's biocompatibility testing capabilities.

Developing Cleaning Methods for Successful Validation

Published: October 12, 2020

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Key Considerations for Executing Clinical Trials for Dual 510(k) and CLIA Waiver Applications

Published: August 11, 2020

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AATCC TM 100-2019: Assessment of & What It Means for Medical Textiles

Published: July 30, 2020

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The IVDR Compliance Roadmap: From Start to Finish

Published: July 8, 2020

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FDA Releases Final Guidance on Bone Anchor Premarket Notification 510(k) Submissions

Published: March 5, 2020

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Mapping QMS to EU IVDR Requirements: 3 Key Takeaways to Effectively Strategize QMS Implementation

Published: December 30, 2019

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The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval

Published: December 3, 2019

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Key Requirements of Post-Market Surveillance under IVDR

Published: November 18, 2019

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IVDR Technical Documentation: 5 Critical Parameters of Change You Must Understand

Published: October 30, 2019

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Preparing for MDR: Test In-House or Outsource?

Published: October 8, 2019

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