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.
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 [...]
4 Strategies for Keeping Current In An Evolving World of Compliance At a half-day conference of the American Society for Quality (ASQ) conference whose theme was Quality is Not a Goal – It’s a Way of Life, Julie Larsen provided industry professionals essential tips and best practices to stay current as compliance trends evolve. [...]
Validation: When is a Test Method Not a Test Method? How can one site conduct and pass several gage Repeatability and Reproducibility (R&R) studies on a product, yet another site fails the gage R&R on the same product using the same gage and the same test methods? In his presentation to industry professionals at [...]
BioTeknica Awarded Highest Standards Certification: ISO 9001:2015 BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality Management (QM) system. For life science manufacturers, it means BioTeknica has a rigorous QM system and standards in place throughout its operations and that every engineer and team member in our organization is [...]
Ready, Set, Go! Coaching Your Team to Validation Success Device manufacturers often don’t have the time or the internal resources to train their staff. BioTeknica’s Ready Set Go! is a proprietary, interactive, hands-on coaching program where our personnel help you successfully train your team members in developing and executing validation protocols, performing test result analysis, and [...]
Get to the Head of the Class: Lunch & Learn Series at BioTeknica's New Learning Center BioTeknica recently launched Lunch & Learn, a series of interactive training sessions for professionals in the device industry on timely topics designed to help you stay abreast of best practices, trends, regulations, and processes that impact the [...]
Julie Larsen Joins FDANews Medical Device Conference Advisory Board Congratulations to BioTeknica principal Julie Larsen for her recent invitation and acceptance to join the FDAnews Medical Device Conference Advisory Board. Julie Larsen, Principal, Director, Inspection Readiness, BioTeknica BioTeknica’s reputation as an expert regulatory compliance consulting firm has grown within the medical device industry [...]
Charity: BioTeknica's Helping Hands Every year for the past three and a half years, BioTeknica has partnered with Catholic Relief Services (CRS) to support Helping Hands, a joint program of Stop Hunger Now and CRS. Most recently, BioTeknica associates and their families met at the Belen Jesuit Preparatory School in Miami to help package nutritious meals [...]
FDA Program Realignment: New Model for Device Approval & Inspection Efficiency The FDA Center for Devices and Radiological Health (CDRH) has submitted a reorganization plan to the agency for review, and the new program model is designed for greater inspection and approval efficiency. The realignment will impact how medical device companies interact with the agency. Find out how the agency thinks device manufacturers will benefit from [...]
