Our core competencies
We stand by you in a more and more complex regulatory environment. Together, we work out a solution perfectly tailored to your requirements.
Biological Safety Evaluation and Toxicological Risk Assessments (ISO 10993-series)
Biological Safety Evaluation.
Toxicological Risk Assessments.
Planning of chemical analyses.
Planning of in-vivo analyses.
Planning of in-vitro analyses.
- Documentation, planning and execution of process validations, for instance, cleaning processes, sterilisation processes using ETO, gamma and saturated vapour.
- Revision and optimisation of reprocessing information in accordance with ISO 17664 for central sterilisation.
- Development and support for microbiological and/or chemical monitoring of the cleaning and sterilisation process, process water and your clean rooms.
Deviations in Quality & Complaint Handling (NC, CAPA, Complaints)
- Investigation, assessment and remedying of client complaints and deviations in quality (NC, CAPA).
- Carrying out investigations of deviations and analysis of the failure root cause.
- Definition of correction and prevention measures according to 21 CFR 820 and ISO 13485.
Medical Device Regulatory Affairs (RA)
- Drawing up and dealing with regulatory approval world-wide of your medical products.
- Execution of technical documents for international registration and approval.
- Preparation of an approval strategy along with planning and implementing it.
- Development of packaging systems, sterile barrier systems and secondary packaging, taking functionality and usability into consideration.
- Drawing up validation documentation along with planning and supporting the carrying out of transport validations according to international standards and guidelines.
- Execution and optimisation of the technical documentation, such as specifications and drawings.
Verification and Validation (V&V)
- Drawing up validation documentation along with planning and supporting the carrying out of IQ, OQ and PQ of installations.
- Planning and co-ordination of biocompatibility studies along with chemical, physical and mechanical tests.
Product Development (R&D)
- Supporting the development of new products with focus on aspects of reprocessing.
- Planning and co-ordinating biocompatibility studies.
- Regulatory and standard gap analysis and introduction of the RA perspective in development projects.
Supplier Quality Management (SQM)
- Independent planning of your annual audit plan. Timely execution of supplier audits according to EU MDR
REGULATION (EU) 2017/745, ISO 13485 and 21 CFR 820, and your in-house specifications.
- Preparation of audit reports and of the concluding management report.
- Processing deviations arising from the audit in collaboration with the affected suppliers and your in-house interfaces.