We consult on the following medical device regulations:
- FDA's Quality System Regulation (QSR)
- ISO 13485
- Medical Device Directive (MDD)/Medical Device Regulations (MDR)
- Canadian Medical Devices Regulations (CMDR)/CMDCAS
- Japanese MHLW Ordinance 169
- Related standards and regulations.
Specifically, we help clients in the following ways:
- Internal audits
- Due diligence audits
- Create procedures
- Review/edit procedures
- Review risk management program/risk analyses
- Prepare/perform customized training
- Supplier audits
- Review technical files/design dossiers
- Review FDA submissions [510(k), PMA]
- Assist in preparation of material for submissions
- Provide information for management review on new or revised regulatory requirements
- Serve as independent reviewer in design reviews
- Serve as temporary head of Quality Assurance
- Attend training or conferences on your behalf and train your employees or management in turn