Medical device design & engineeringYaniv2020-08-12T10:08:00+00:00
Design & engineering in the medical device filed
Factories, manufacturing facilities, laboratories, manufacturing/assembly/packaging processes in the fields of medical devices, require a combination of Engineering know-how, practical experience and a thorough understanding of the unique principles that characterize this industry.
Understanding customer needs, regulatory requirements, reflected in the Ministry of Health, FDA and European guidelines, is essential to establish a facility that will produce a safe and high-quality medical Accurate and orderly documentation, adhering to all the rules, using appropriate models for managing complex engineering projects, assimilating quality methodologies, proper engineering conditions and production among contractors, managers and project employees, and selecting the most appropriate technologies for customer needs are essential steps for obtaining product quality and facilities in compliance with the current regulatory standards. At the end of the project, the facility should be validated thoroughly.
Success in audits that will be conducted at the facility by the health authorities after accreditation is imperative to obtain approval for factory production and marketing authorization.