MDR COMPLIANCE IN 7 STEPS
Since May 26th 2021, the Medical Device Regulation is fully applicable. Hence, all processes related to design, industrialization, manufacturing, marketing and market surveillance have to be aligned with the quality management system which must be compatible with ISO 13485:2016 and/or USA QSR.
We'll help you to get your products fully compliant by using our 7 steps strategy:
1. Project kick-off
- Group products to stay in market/ go exit
- Create project plan, plan resources, install team, determine competencies
- Form product families, define transition periods
- Identify and inform partners
1. Project kick-off
2. Scope definition
- Specify intended purpose and -use, formulate value proposition
- Examine alternatives (methods, new technologies and manufacturing processes)
- Collect UDI data
- Make final decision which products stay in market
- Submit application to Notified Body
- Establishment of a group of experts necessary?
- Update project plan
3. Define class and procedures
- Final decision which products will be further marketed
- Submit application to the NB (audit, approvals)
- Establishment of a group of experts necessary?
- Update project plan
3. Define class and procedures
4. Update technical files
- Complete MDR gap analysis, review new requirements
- Catch up on missing validations
- Update PMS System, collect data, update/perform clinical evaluation
- Update product labeling and all instructions
- Update risk management file, plan postmarket clinical follow up (PMCF)
5. QM-System & PMS update
- Update QM system to ISO 13485:2016 compliance and test by trial
5. QM-System & PMS update
6. Implement UDI system
- Implement UDI System, allocate Single Registration Number (SRN) and report data to EUDAMED
7. Product auditing & approval
Product ready to sell!
7. Product auditing & approval
