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Quality Engineering
Are you able to resolve the root cause?
Quality Engineering services using proven methodologies to resolve life science engineering challenges
BIOTEKNICA COMMUNITY OUTREACH
BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa! When not traveling around the world for client business, BioTeknica team members can be found [...]
TEAM MEMBER PROFILE Meet Ruben Capo: Co-Founder, Quality Engineer, Part-Time Adventurer
Meet Ruben, mild-mannered BioTeknica Principal, Co-Founder, and Senior Quality Engineer. Think you know him? Think again. When you talk to [...]
INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June 2020 in [...]
BIOTEKNICA OPERATING AT FULL CAPACITY Company Implements Business Continuity Plan During COVID-19 Crisis
BioTeknica and its sister companies, Qualified Data Systems and Synergis, are here for you. We are open and operating [...]
2 New Laws Impact Device Industry
2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws [...]
4 Strategies for Keeping Current In An Evolving World of Compliance
4 Strategies for Keeping Current In An Evolving World of Compliance At a half-day conference of the American [...]
Validation: When is a Test Method Not a Test Method?
Validation: When is a Test Method Not a Test Method? How can one site conduct and pass several [...]
Operational Review
Operational Review & Optimization for Medical Device and Pharmaceutical Companies Cost Reduction Strategies Business Process Re-engineering (BPR) Process Optimization/Improvement Process Control and Automation [...]
BIOTEKNICA COMMUNITY OUTREACH
BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa! When not traveling around the world for client business, BioTeknica team [...]
TEAM MEMBER PROFILE Meet Ruben Capo: Co-Founder, Quality Engineer, Part-Time Adventurer
Meet Ruben, mild-mannered BioTeknica Principal, Co-Founder, and Senior Quality Engineer. Think you know him? Think again. [...]
INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled [...]
Modernizing the FDA Workforce
Modernizing the FDA Workforce A strategic priority identified by the FDA earlier this year is to strengthen the FDA’s scientific workforce by investing [...]
BioTeknica is an ISO 9001:2015 Certified Company
BioTeknica is an ISO 9001:2015 Certified Company BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality [...]
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 [...]
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 [...]
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 [...]
Julie Larsen Receives Association of Food and Drug Officials (AFDO) Award
Julie Larsen Receives the Association of Food and Drug Officials (AFDO) Associate Member Award International Honor for Exemplary Success and Leadership in Drug & [...]