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.
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 [...]
Medical Device Cyber Risk Management Armin Torres, Principal, Qualified Data Systems, a BioTeknica sister company. Medical Device Cyber Risk Management is the marriage between Safety and Security. It may seem an afterthought that we should be innately capable of living on a safe and secure planet as humans, but what about the connected devices [...]
Inspection Data and Areas of Emerging Concern CDRH Publishes 2015 Annual Medical Device Quality System Data Reviewing and understanding the latest data on inspections, inspectional observations, and Warning Letter citations is critical for life science manufacturers. In support of the FDA’s transparency and Case for Quality initiatives, FDA’s Center for Devices and Radiologic [...]
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 answer? Baxter Diagnostics. In 1984, Romney started the global private equity firm, Bain Capital, and about a decade later purchased Baxter Diagnostics. After the buyout, Ruben, an electrical engineer working [...]
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 a valuable resource on trends and initiatives that impact drug, device and diagnostics manufacturers. In our newsletter, we’ll share best practices from FDA, EU and industry experts including our own [...]
