PEC has grown into one of the leading consultancy companies in Denmark within the field of production of medical devices. We can contribute in most phases of a device project.
- Advising R&D on the design to ensure that your device is ready for mass production.
- All the project design phases from basic design of the assembly equipment through validation and ramp up
- Advising within device regulations
- Knowledge transfer from R&D to production
PEC has a wish to contribute to your business results and project execution by ensuring that you get the best possible advice form product development to establishing of final production lines.
PECs foundation as an engineering company, with high focus on qualification assurance, that we can support your company within all project phases and with both technical – and project management competences.
- Project Management during all design phases
- Support for Design for manufacturing
- Support for Design for Assembly
- Technology Transfer from R&D to Production
- Product- and process Risk Assessments (cf. to ISO 14971)
- DOE testing covering processes and equipment
- Design of Assembly processes
- Supplier Evaluation and Audit (cf. to ISO 9001, ISO 13485)
- Design Qualification
- Commissioning and Qualification
- Validation Execution and Final Reporting
- Design and validation of Packaging equipment
- Validation of Sterilization processes
- Production Outsourcing