Quality management systems must comply with the regulatory requirements for medical devices in the jurisdiction where the products are placed on the market.
Whatever your specific needs and target markets, we can prepare a customised Quality Manual and a full set of standard operating procedures suitable for your company, in compliance with ISO 13485 and the regulatory requirements of:
- Australian Therapeutic Goods (Medical Devices) Regulations
- EU Medical Device Regulation 2017/745 (MDR)
- US FDA Quality System Regulation (QSR)
- International Medical Device Single Audit Program (MDSAP)
Certification to the ISO 13485 standard is not mandatory but highly recommended in preparing the company’s quality systems for auditing by regulatory agencies, and for marketing the company’s credentials.
Medical devices must comply with requirements of safety and performance defined in regulations and relevant guidance documents. A well-documented technical file can make the difference between a fast approval and a lengthy, painful review process. We can assist with technical documentation preparation and review, and ongoing compliance for design changes. Key areas include:
- Risk classification and regulatory strategy
- Submission-ready tech file documentation
- Labelling, user manuals, advertising
- Unique device identification (UDI)
- Risk management
- Verification and validation (V&V), testing to standards
- Clinical evaluation
If you would like to discuss how Market Access (AUS) Pty Ltd can assist you with your regulatory requirements for medical devices, please contact Val Theisz at firstname.lastname@example.org or use our general enquiries email: email@example.com.