Monthly Archives: October 2018

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2 New Laws Impact Device Industry

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 [...]

By |2021-02-12T03:26:12+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

4 Strategies for Keeping Current In An Evolving World of Compliance

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. [...]

By |2021-02-12T03:26:03+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Validation: When is a Test Method Not a Test Method?

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 [...]

By |2021-02-12T03:25:52+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

BioTeknica Awarded Highest Standards Certification: ISO 9001:2015

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 [...]

By |2021-02-12T03:25:37+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Ready, Set, Go! Coaching Your Team to Validation Success

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 [...]

By |2021-02-12T03:25:26+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Get to the Head of the Class: Lunch & Learn Series at BioTeknica’s New Learning Center

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 [...]

By |2021-02-12T03:25:13+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Julie Larsen Joins FDANews Medical Device Conference Advisory Board

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 [...]

By |2021-02-12T03:25:03+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Promotion Announcement

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 [...]

By |2021-02-12T03:24:32+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments

Charity: BioTeknica’s Helping Hands

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 [...]

By |2021-02-12T03:24:19+00:00October 5th, 2018|Blog, S3 Compliance Matters|0 Comments
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