BFK Solutions provides consulting services in medical device manufacturing including traditional devices, combination devices, and devices using 3D printed materials.

At BFK Solutions, we work with start-up companies that are looking to scale up production. We also work with established companies with validation challenges or process control problems including groups facing unavoidable changes in materials of construction and process fluids. We help clients avoid regulatory issues. We expedite resolution of regulatory problems. We help clients achieve rugged, rational, defendable processes that can be readily validated and maintained. Our education and experience in the biological sciences combined with our expertise in developing high-value devices provides a practical perspective.

Workshops, presentations, publications, standards, guidance documents

Interesting and full of information; comprehensive and clear; helpful; very instructive; excellent information. Both speakers (Barbara Kanegsberg; Ed Kanegsberg) were fantastic! Both speakers were very open for discussion. I liked the interaction with the audience.
Attendee responses
"Cleanliness Issues for Biomedical Devices"
Workshop at MEDTEC Germany

BFK Solutions conducts public and private workshops for those involved in medical device manufacturing. Ed Kanegsberg moderated a breakout session at an FDA workshop concerned with medical devices produced using additive manufacturing.  As an invited speaker at ASTM and NIST, Barbara Kanegsberg has delivered presentations concerning precision cleaning and materials compatibility issues relating to medical devices. Barbara conducted invited seminars and discussion sessions for residents and faculty at the University of Southern California, Graduate School of Periodontics.   Because manufacturers supplying components to medical device manufacturers are increasingly concerned with providing a quality product to the final assembler, we also present and write articles addressing supply chain issues. Please refer to our publications section

As cleaning and contamination control experts, BFK Solutions participate in ASTM working groups.  We are active in the ASTM F04 committee concerned with standards and guidance documents for cleanliness, surface quality, and leachable residue in single use and reusable medical devices. We are reviewing ASTM standards that would be most pertinent to issues of additive manufacturing  (3D printed materials).