SCC GmbH, founded in 1989, is one of Europe’s largest regulatory consulting companies, supporting its global customers with regulatory and scientific services of highly regulated products i.a. medical devices, pharma (pre-clinical), cosmetics, agrochemicals and biorationals, biocides and chemicals.
In the field of medical devices we provide our customers with the following services:
- Comprehensive consulting services for product development and in-market compliance vs. MDR (EU) 2017/745.
- Individual gap analysis vs. MDR (EU) 2017/745 requirements and recommendations how to overcome gap findings.
- R&D support: ISO 13485 procedure definitions, REACH services, risk assessments with modern methods, e.g. QSAR or statistical calculations or comparisons.
- Assisting in biological evaluation of medical devices according to ISO 10993 (risk assessment, study selection, organisation and evaluation).
- Literature search and supply service, e.g. for clinical evaluation following MEDDEV 2.7/1 revision 4 Annex A4 and A5.
- Clinical evaluation following Article 61 and Annex XIV MDR (EU) 2017/745 and MEDDEV 2.7/1 revision 4.
- Qualification and validation of your products as well as production and quality control equipment and methods.
- International approval of your products