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Quality Engineering
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SUCCESS STORIES Bringing an Inadequate CAPA Process to Effectiveness
Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their [...]
ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?
Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) [...]
ASR IS OVER! HOW DO VMSR & NEST IMPACT YOUR ORGANIZATION?
Feeling unsure of how the FDA’s updated reporting processes will affect you? You’re not alone. BioTeknica SMEs delved into the real-world [...]
BioTeknica Awarded Highest Standards Certification: ISO 9001:2015
BioTeknica Awarded Highest Standards Certification: ISO 9001:2015 BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, [...]
Ready, Set, Go! Coaching Your Team to Validation Success
Ready, Set, Go! Coaching Your Team to Validation Success Device manufacturers often don’t have the time or the [...]
Get to the Head of the Class: Lunch & Learn Series at BioTeknica’s New Learning Center
Get to the Head of the Class: Lunch & Learn Series at BioTeknica's New Learning Center BioTeknica recently [...]
Julie Larsen Joins FDANews Medical Device Conference Advisory Board
Julie Larsen Joins FDANews Medical Device Conference Advisory Board Congratulations to BioTeknica principal Julie Larsen for her recent [...]
S3 Method – Simple, Systematic, Sustainable
S3 Method: Simple, Systematic, Sustainable Can You Be Compliant While Keeping Costs Down & Positively Impacting Your Bottom Line? [...]
SUCCESS STORIES Bringing an Inadequate CAPA Process to Effectiveness
Did you know that one of the top three causes of 483 observations is because manufacturers fail [...]
ASK A BIOTEKNICA SME HOW TO VALIDATE A PROCESS WITH A “HIGH DEGREE OF ASSURANCE” AND WHAT DOES THAT EVEN MEAN?
Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our [...]
ASR IS OVER! HOW DO VMSR & NEST IMPACT YOUR ORGANIZATION?
Feeling unsure of how the FDA’s updated reporting processes will affect you? You’re not alone. BioTeknica SMEs [...]
Medical Device Cyber Risk Management
Medical Device Cyber Risk Management Armin Torres, Principal, Qualified Data Systems, a BioTeknica sister company. Medical Device Cyber Risk Management is the marriage between [...]
Inspection Data and Areas of Emerging Concern
Inspection Data and Areas of Emerging Concern CDRH Publishes 2015 Annual Medical Device Quality System Data Reviewing and understanding the latest data on [...]
BioTeknica: The Inside Story
What do billionaire and 2012 presidential candidate Mitt Romney and BioTeknica co-founders Ruben Capo, Braulio Ortiz and Jorge Rodriguez all have in common? The [...]
Timely, Critical Regulatory Information
Timely, Critical Regulatory Information You’re busy and need timely bite-sized bits of critical regulatory and compliance information. We hope you’ll find BioTeknica’s S3 Compliance Matters to be [...]
FDA & EU Requirements and Expectations
5 Things You Should Know from the 2015 Association of Food & Drug Officials (AFDO) Conference If you didn’t have a chance to attend [...]
Successful Outcomes One Client at a Time
Successful Outcomes One Client at a Time Recently, BioTeknica assisted a leading medical device manufacturer to successfully address a previous FDA Warning Letter by [...]