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 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 [...]
Upcoming Events BioTeknica will be participating in a series of events and conferences. Please see our end-of–year calendar of events.
Promotion Announcement We are pleased to announce the promotion of several BioTeknica team members. Please join us in congratulating them all! Brian Dawson has been promoted to Sr. Quality Consultant and Regulatory Compliance Project Manager. In this role, Brian will have expanded responsibilities for project management for Regulatory Compliance services as we look to improve our [...]
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 [...]
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) [...]
