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.

Sterility Assurance
  • 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.
Packaging Development
  • 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.