Sterilization Consulting Services, also has expertise in quality systems. We have been involved in Quality Assurance for firms ranging in size from the startup to the multi-national. We recognize that the world of Medical Device manufacturing is under increasing regulatory pressure, coupled with an ever present need to reduce cost. Sterilization Consulting Services can assist on a project basis to handle a specific issues which does not result in the addition of staff.
Services provided include:
- FDA and CE mark gap analysis, including pre-FDA auditing
- Internal and Supplier auditing
- Responses to FDA 483s and Warning letters
- Assistance in System development or improvements
- Customer Complaints
- CAPA systems
- FMEA
- Evaluation and/or Development of Business Strategies