Preparing Biocompatibility Risk Assessments for International Registration
Published: October 26, 2020
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Responding to Regulatory Requests for Additional Information
Published: October 16, 2020
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Developing Cleaning Methods for Successful Validation
Published: October 12, 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 Secret Recipe for Testing Success
Published: July 13, 2020
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Streamlining Submissions with Product Adoption for Radiation Sterilization
Published: June 11, 2020
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Stop Letting GLP Stunt Your Chemistry Studies
Published: June 11, 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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Preparing for MDR: Don’t Forget About Class I Reusable Devices
Published: February 18, 2020
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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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Radiation Sterilization: Verifying Dose Survivors
Published: November 18, 2019
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Preparing for MDR: Test In-House or Outsource?
Published: October 8, 2019
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Preparing for MDR: Partner Up
Published: September 3, 2019
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Guide to Package Integrity & Validation Testing Under ISO 11607 and MDR + FAQ
Published: September 1, 2019
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Package Testing and Validation: Interplay Between ISO 11607 Updates and MDR
Published: June 13, 2019
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