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We’re a consulting firm specializing in regulatory compliance, FDA inspection readiness, quality engineering, and validation projects for the medical device, biological, and pharmaceutical industries.
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Due to the COVID-19 pandemic, the Association of Food and Drug Officials (AFDO) Annual Conference, originally scheduled for June 2020 in Phoenix, AZ, has been canceled. BioTeknica is actively helping AFDO plan for medical device webinars to be held later this year. For the latest information on the webinars and new annual conference date, [...]
BioTeknica and its sister companies, Qualified Data Systems and Synergis, are here for you. We are open and operating at full capacity with the ability to access client technology systems remotely, when necessary. Learn about key elements of our continuity plan… Please be assured that in the event of further [...]
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 Management System. Life science manufacturers can further benefit from the knowledge that every engineer, scientist and team member throughout our organization is responsible for delivering innovative customer-focused engineering and regulatory [...]
FDA Program Alignment & The New CDRH in Bite-Sized Chunks Changes at the FDA are impacting life science manufacturers. In 2013 the Agency initiated an effort to realign its programs, streamline and restructure the organization so that it could keep up with new advances in science, product complexities, and globalization. The FDA’s Program [...]
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 lot of ground to cover in the standard’s recent revision. The main benefit of the revision is greater transparency of the requirements and alignment between the regulators, auditing bodies, and [...]
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 Safety Please be assured that in the event of further disruptions, we are prepared to continue with our services remotely in a secure environment [...]
BioTeknica at Upcoming Conferences: 2015 – 2016 BioTeknica will be participating at the following upcoming conferences. We look forward to seeing you there! 10th Annual FDA news Inspection Summit: November 4-6, 2015 in Bethesda, MD. The number one event for Quality, Compliance and Inspection Readiness Professionals. Hear from seasoned industry professionals and real-life FDA [...]
