Monthly Archives: January 2017

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Lean Management Systems and the New Normal

Lean Management Systems and the New Normal 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 industry there has been [...]

By |2021-02-12T03:00:39+00:00January 2nd, 2017|Blog, S3 Compliance Matters|0 Comments

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

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

By |2021-02-12T03:03:03+00:00January 2nd, 2017|News|0 Comments

ISO 13485: WHAT’S NEW? FIRST REVISION IN 13 YEARS

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

By |2021-02-12T03:04:02+00:00January 2nd, 2017|News|0 Comments
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