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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.
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 management structure to align its staff by FDA-regulated product instead of geographic region. At a symposium earlier this year, an FDA official provided an update of key changes at the ORA [...]
New FDA Communications Guidelines For Inspections Medical device companies have new FDA contacts and new guidelines to communicate with the FDA regarding their inspections. Find your division and contacts and learn more about the guidelines. The Office of Medical Device and Radiological Health Operations (OMDRHO) provides advice to the Office of Regulatory Affairs (ORA) [...]
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 [...]
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 [...]
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 [...]
