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.
Modernizing the FDA Workforce A strategic priority identified by the FDA earlier this year is to strengthen the FDA’s scientific workforce by investing in the scientific and clinical expertise of its staff. To keep up with the complexity of modern devices and improve efficiency, the FDA is investing in enhancing the scientific and [...]
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 [...]
Lean Management Systems and the New Normal Miguel E Guerrero, Lean Sensei, Managing Partner, Synergis Corp., a BioTeknica sister company The output of any process, whether business, operational, or economic, should result in outcomes that exhibit high quality, low cost, and timely delivery. Yet, in the medical device and health industry there has been [...]
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 [...]
5 Things You Should Know from the 2015 Association of Food & Drug Officials (AFDO) Conference If you didn’t have a chance to attend this year’s AFDO Annual Educational Conference, below are five important take-away points from the Drugs, Devices and Cosmetics sessions. 1. EU Enforcement: Notified Bodies Now Conducting Unannounced Audits of Manufacturers, [...]
Successful Outcomes One Client at a Time Recently, BioTeknica assisted a leading medical device manufacturer to successfully address a previous FDA Warning Letter by helping them to improve their quality systems, remediate records, and organize, prepare and support the FDA re-inspection process. “We were able to make significant improvements over the past year and [...]
We’re passionate about figuring out how to expertly integrate both the intent and interpretation of regulations to your specific products. So ask yourself how we can assist you. Regulatory Compliance: How do you achieve compliance while managing your business needs? Regulatory agencies demand that manufacturers maintain compliance throughout all stages of a product’s lifecycle, [...]
