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Quality Engineering
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FDA Inspection Readiness
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare for your next FDA [...]
Regulatory Compliance
Regulatory Compliance We not only know what to do but – how to do it. We ensure that your quality [...]
Lean Quality Solutions
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, an IQVIA business, offers comprehensive [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
FDA Inspection Readiness
S3 FDA Inspection Readiness Services Are You Ready? Have you done everything possible to prepare [...]
Regulatory Compliance
Regulatory Compliance We not only know what to do but – how to do it. We [...]
Lean Quality Solutions
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, an [...]
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 launched Lunch & Learn, a [...]
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 invitation and acceptance to join [...]
Charity: BioTeknica’s Helping Hands
Charity: BioTeknica's Helping Hands Every year for the past three and a half years, BioTeknica has partnered with Catholic Relief Services (CRS) to support Helping [...]
FDA Program Realignment: New Model for Device Approval & Inspection Efficiency
FDA Program Realignment: New Model for Device Approval & Inspection Efficiency The FDA Center for Devices and Radiological Health (CDRH) has submitted a reorganization plan [...]
FDA’s Office Of Regulatory Affairs Realigned
FDA's Office Of Regulatory Affairs Realigned The FDA’s Office of Regulatory Affairs (ORA), the lead office for agency field activities, has changed its [...]
New FDA Communications Guidelines For Inspections
New FDA Communications Guidelines For Inspections Medical device companies have new FDA contacts and new guidelines to communicate with the FDA regarding their [...]