Newsletter: S3 Compliance Matters

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ISO 13485: What’s New? First Revision in 13 Years

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  It’s been 13 years since ISO 13485 was last updated, and there was a lot of ground to cover in the standard’s recent revision. The main benefit of the revision is greater transparency of the requirements and alignment between the regulators, auditing bodies, and manufacturers ...

FDA Program Alignment & The New CDRH in Bite-Sized Chunks

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Changes at the FDA are impacting life science manufacturers.  In 2013 the Agency initiated an effort to realign its programs, streamline and restructure the organization so that it could keep up with new advances in science, product complexities, and globalization.  The FDA’s Program ...

Lean Management Systems and the New Normal

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Miguel E Guerrero, Lean Sensei, Managing Partner, Synergis Corp., a BioTeknica sister company The output of any process, whether business, operational, or economic, should result in outcomes that exhibit high quality, low cost, and timely delivery. Yet, in the medical device and health ...

Inspection Data and Areas of Emerging Concern

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CDRH Publishes 2015 Annual Medical Device Quality System Data Reviewing and understanding the latest data on inspections, inspectional observations, and Warning Letter citations is critical for life science manufacturers. In support of the FDA’s transparency and Case for Quality ...

Medical Device Cyber Risk Management

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Armin Torres, Principal, Qualified Data Systems, a BioTeknica sister company. Medical Device Cyber Risk Management is the marriage between Safety and Security. It may seem an afterthought that we should be innately capable of living on a safe and secure planet as humans, but what about ...
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