The companies in the medical devices sector are under pressure due to new product development, compliance with regulations, improvement of products quality and operational processes.
Skytechnology supports Customers in the devices development and marking, thanks to the expertise in product/process compliance and in product development.
Skytechnology offers a whole set of design services:
- Hardware board design, complex FPGA design, Prototyping (also at system level)
- Software development;
- Test benches implementation and construction
- Quality Management System, SOP, CAPA.
- Risk Management of medical device and software
- Validation of the device and software: IEC 62304, 21 CFR Part 11, GAMP5.
- Preparation of the Technical File of the Medical Device
- Validation of Test Benches
- Product marking according the European (CE), US and Chinese scheme
- Preparation of Health Agencies and Notified Body Audits
- Training courses on Standards ISO 14971 e IEC 62304.