Technical Development Service
Medical Device Design Control, Product Development & Quality Testing Product Development Management Design Control Process/Design and Implementation Regulatory Compliance Regulatory, Quality & Clinical Trial Planning Product Development and Design Control Process and Test Method Development Training & Education Risk Analysis Due Diligence Evaluations
Validation
Validation Services BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at both small and large [...]
Regulatory Services
Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory support for all phases [...]
FDA Inspection Readiness
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare for your next FDA [...]
BIOTEKNICA COMMUNITY OUTREACH
BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa! When not traveling around the world for client business, BioTeknica team members can [...]
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 [...]
INDUSTRY NEWS ROUNDUP
Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June [...]
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 [...]
Technical Development Service
Medical Device Design Control, Product Development & Quality Testing Product Development Management Design Control Process/Design and Implementation Regulatory Compliance Regulatory, Quality & Clinical Trial [...]
Validation
Validation Services BioTeknica provides proven validation methodologies that have been successfully implemented for our clients at [...]
Regulatory Services
Regulatory Services for Medical Device & Pharmaceutical Industries BioTeknica provides expert clinical and regulatory [...]
FDA Inspection Readiness
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare [...]
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 [...]
2 New Laws Impact Device Industry
2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws will impact the device industry: [...]
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 Society for Quality (ASQ) conference [...]
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 gage Repeatability and Reproducibility (R&R) [...]
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, for its Quality Management (QM) [...]
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 internal resources to train their [...]