The global medical device market is a heterogeneous, innovative, diverse, and dynamic field, huge in its variety and potential, and is also expected to show high growth rates in the future. Technological developments in the last two decades have not skipped the field of medical devices. Many technologies from other fields are also finding their way into the medical device industry, for example, software, AI, Big Data, electronics, nanotechnology, monitoring technologies and integrated medical device-medicines and combination products. Regulatory requirements for medical devices are not as stringent as those for pharmaceuticals, but are still considered to be more stringent than those for other industries.
Medical equipment can be fixed, reusable or disposable, and may be used in hospitals and operating rooms, clinics or for home care.
Sometimes medical equipment size and design must be adapted, due to anatomical differences between different populations or patients, or to optimize instrumentation and products for the specific needs of the patients.
Israel is considered a world leader in medical device development, thanks to information- and technology-sharing between local pharma and high-tech industries. Many leading global medical device companies develop and manufacture their medical devices in Israel.
Our medical device consulting services
What do our customers say?
“Eran from Bio-Chem supported and Counseled Medimor Ltd. during transformation from antenna Manufacturer company named “Galtronics” to be a one of the leading Medical Device turnkey subcontractor in Israel. The project included state of the art clean rooms facility design and inspection, qualifications and GMP training. I enjoyed working with Eran and Bio-Chem team. They performed excellent professional work and were very committed to the project with the highest standards a customer can ask for. Eran and Bio-Chem Completed the project tasks in satisfactory quality level and in a timely manner”
Ofer Sagi, Quality Engineering manager at J&J
“I have used Bio-Chem, for external GMP inspection in one of our TEVA facilities. The inspection was done in a very professional manner by Bio-Chem team. The inspector was well skilled and experienced; and the inspection was thorough and efficient. Thank you!”
Dr. Gali Guzikevich, Sr. Director GMP QA, Innovative R&D, Teva
“Eran Yona performed two GMP and one ISO audits that evaluate our contractors. Excellent performance, deep cGMP/ISO knowledge, customer orientation and fasts communication characteristic. Final audit reports were provided during a really short time, and additional questions that I had were answered quickly and accurately. It would be a pleasure to work with Eran on any project again in the future”
Georgy Laskov, QP at Zoetis
“For the Bio-Chem team, working with you is professional and relevant, with a pleasant and courteous reference. On this occasion, we thank you for your support throughout the period we work together, and we would love to recommend Bio-Chem as an excellent and professional company.”
Dr. Yael Koresh, QA Minipac
“Many thanks to Eran Yona and the Bio-Chem staff. The staff was invited on a short notice to a new facility, the work was done professionally while meeting very tight and rigid schedules. Professional team with lots of patience and courtesy. I would love to recommend Biochem as an excellent and professional company ”
Simha Vazana, QA Manager Phibro
“Eran Yona and Bio-Chem has many years of experience in industrial pharmaceuticals from design to construction, validation and GMP manufacturing. In all our interactions I was very satisfied with their recommendations and practical suggestions. They helped the companies I was involved with to overcome practical manufacturing and regulatory obstacles”
Adrian Harel, CEO at Medicortex Finland Oy
“Eran Yona and the Bio-Chem team have consulted for Sigma Aldrich on GMP and Validations towards an FDA regulatory inspection. The company was professional and service-oriented throughout the entire project. All documentation supplied was well written and detailed. Bio-Chem’s support has allowed our organization to complete the project on-time and successfully. Their guidance has improved our company’s regulatory compliance and manufacturing processes.”