Medical Devices

For Medical Devices we mean: "any instrument, device, implant, substance or other product, used alone or in combination, including the computer software used for its correct functioning, is intended by the manufacturer to be used in humans for the purpose of: - diagnosis, prevention, control, therapy or alleviation of a disease; - diagnosis, control, therapy, alleviation or compensation of an injury or handicap; - study, replacement or modification of the anatomy or of a physiological process; - intervention on the conception, whose main desired action in or on the human body is achieved by pharmacological, immunological or metabolic means, but whose function can be assisted by these means ". The Medical Devices Directive entered into force on January 1, 1995 and had a "transition" period until June 13, 1998. During this period, manufacturers were able to choose to follow the national controls existing on December 31, 1994. Therefore, all medical devices "placed on the market and put into service" from June 14 onwards must comply with the Medical Devices Directive and carry the CE mark, where required. The regulatory assistance provided by Bio Chem S.r.l relates to technical advice in the biomedical sector. Our consulting services are based on the professionalism of our technicians in order to lead companies that need to produce Medical Devices in accordance with the UNI EN ISO 13485: 2016 standard and support them in the preparation of the Technical File, an indispensable requirement for registration on the portal of the Ministry of Health. Bio Chem S.r.l. has organized a qualified team supported by internal procedures, suitable to meet the needs of customers by ensuring a timely response to the questions raised regarding: • issues related to regulatory aspects on medical devices, product classification, CE marking, marketing authorization, export authorizations, drafting of labeling etc .; • preparation of product technical documentation: technical files, risk management assessment pursuant to UNI CEI EN ISO 14971, analytical studies and clinical trials; • problems relating to the regulatory aspects of production workshops, voluntary certification 13485: 2016 and maintenance of authorizations; • problems relating to the technical aspects of production workshops: verification of compliance of production environments with reference standards / laws, including classified environments; implementation of plant qualification and process validation procedures; • preparation and implementation of company Quality Management Systems according to UNI EN ISO 9001: 2008 and UNI EN ISO 13485: 2016 standards. • Collaboration with the company Quality Management in the preparation of the QMS or assumption of the role of external QMS: execution of internal audits, management of relations with certification bodies.

NEWS - BIO CHEM S.R.L.