Your probability of success increases the earlier and more thoroughly you prepare – our proven processes fully prepare your organization for any regulatory challenges.
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.
Lean Quality Solutions for Medical Device & Pharmaceutical Companies Synergis, a sister company of BioTeknica, offers comprehensive lean quality solutions. Lean quality is a set of principles used to achieve improvements in productivity, quality, and lead-time by eliminating waste. The term lean, first used in the late 1980s, described Toyota’s approach to [...]
BIOTEKNICA COMMUNITY OUTREACH Peru, Miami, Africa! When not traveling around the world for client business, BioTeknica team members can be found reaching out to local and global communities, helping to make a difference. Beautifying the Community with Habitat for Humanity Recently, 11 BioTeknica Team members and their families joined Habitat for Humanity of Greater [...]
Meet Ruben, mild-mannered BioTeknica Principal, Co-Founder, and Senior Quality Engineer. Think you know him? Think again. When you talk to clients about Ruben Capo, you hear things like he “provided the insight, expertise and leadership in leading the process validation effort,” or he “is very knowledgeable and an excellent consultant for regulatory matters.” [...]
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, [...]
Did you know that one of the top three causes of 483 observations is because manufacturers fail to correctly use their CAPA processes? How did BioTeknica help a client with an ineffective CAPA process eliminate repeat CAPAs for similar nonconformance events? The results were startling. CAPA ABCs As the “Do Re Mi song” says, [...]
Looking for answers to your regulatory questions? To submit one, please click on Ask a BioTeknica SME and our Subject Matter Experts (SMEs) will share their insights. Today, SME Saeid Ebrahim explains how to validate with a high degree of assurance. Please be assured that in the event of further disruptions, we are [...]
Feeling unsure of how the FDA’s updated reporting processes will affect you? You’re not alone. BioTeknica SMEs delved into the real-world impact of these new reporting programs at a recent conference. Click below to get their Top 5 MDR tips. Please be assured that in the event of further disruptions, [...]
The FDA has modified the regulations regarding adverse event reporting during a pandemic to include COVID-19. Click below for key points about the updated guidance as of March 2020. Please be assured that in the event of further disruptions, we are prepared to continue with our services remotely in a [...]
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 [...]
2 New Laws Impact Device Industry According to a presentation by FDA official Blake Bevill, two recent laws will impact the device industry: 1. Food and Drug Administration Re-Authorization Act (FDARA) of 2017 2. 21st Century Cures Act FDARA Highlights The FDA Reauthorization Act of 2017 (FDARA), an amendment to the Federal Food, Drug, and [...]
