Teaching
A surgical implant company experienced unprecedented growth.
Due to the fast expansion, the company's personnel had little common experience and knowledge of the product design process and management of the risks associated with medical device manufacturing.
BesTech taught a one-day seminar "Design Control according to FDA regulations 21CFR820", and a one-day seminar "Risk Management per ISO 14971".
The company's personnel obtained a common understanding of the design process and risk management procedures as a basis for further growth.
The Notified Body accepted all test results without questions or clarifications and the CE mark was issued promptly.
Litigation Support
A patient had been permanently injured following use of an arthroscopic surgery device.
The patient sued the manufacturer of the device.
Mr. Besseling supported the patient's attorney as FDA and Engineering Expert.
The case was settled, and the attorney wrote: ..."You were very thorough and organized in your preparation and I enjoyed working with a professional who approached the case in this manner"...
Case histories
Some of these case histories show work BesTech has performed in areas not specifically mentioned elsewhere on this website to illustrate the company's flexibility and broad experience.
CE-marking
A startup medical device company was developing novel stents for the cardiovascular market.
To be able to sell and test their product in Europe, the company needed a CE-mark for their stents.
BesTech developed all bench tests and literature studies, managed the tests themselves, and wrote the test reports.