confinis

confinis is a regulatory consultancy specializing in providing advice and services to the medical device, combination product and IVDD manufacturers. confinis core competences are in business practices - quality management and regulatory affairs services (21 CFR Part 820, 21 CFR Part 4, MDR 2017/745, IVDR 2017/746, CMDR, ISO 13485, MDSAP), design control, clinical evaluation, software development life-cycles (e.g. IEC 62304), product risk management (ISO 14971), human factors (IEC 62366-1), electrical safety (IEC 60601-x), validation (computer system validation, process validation, GAMP 5, 21 CFR Part 11 etc.), remediation activities, auditing, training and project management, with particular expertise in new product development...

Medical devices,iso 13485,21 cfr part 4,21 cfr part 820,design control,iec 62304,iec 60601-1,iec 62366-1,mdd 93/42/eec,drug delivery,sor/98-282,iso 14971,ivdd,combination products,21 cfr part 11,regulatory affairs,quality management,mdr 2017/745,ivdr 2017/746,mdsap,and ch-rep

Confinis operates in the Medical equipment manufacturing industry.

Confinis's revenue is 11m - 100m

Confinis has 11 - 50 employees.