FEATURED POST
TO YOU, FROM US
The COVID-19 pandemic has hurled us all into uncharted territory. We question our collective truths; wonder who we are as a nation; ponder our priorities, how we take care of one another, stay healthy, keep our businesses afloat, teach our children, support our heroes, and lift our most vulnerable, all while attempting to keep our anxieties in check. Together we grapple with these questions as a nation, small communities, and as businesses, families, and individuals.
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 [...]
KEY FDA EXPECTATIONS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC
The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click below for key points [...]
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 [...]
Quality Engineering
Quality Engineering Are you able to resolve the root cause? Quality Engineering services using proven methodologies to resolve life [...]
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 [...]
KEY FDA EXPECTATIONS FOR ADVERSE EVENT REPORTING DURING A PANDEMIC
The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click [...]
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 & [...]
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 [...]