I offer several solutions to get your medical devices to market in the fastest possible time, while conforming to all applicable regulatory requirements.

The primary focus is on the medical device lifecycle using a risk based approach, with a strong emphasis on conformance to applicable standards such as ISO 13485, ISO 14971, and global regulatory requirements from target markets.

- General solutions

Risk management

- implementation of an ISO 14971 compliant process
- ISO 14971 “gap analysis”
- risk management process auditing

Quality systems

- implementation of an ISO 13485 or ISO 9001 compliant quality system
- ISO 13485 or ISO 9001 “gap analysis”
- ISO 13485 or ISO 9001 quality system audit
- development and management of a ISO 13485 or ISO 9001 internal audit program

Usability (human factors engineering)

- IEC 62366 compliant process implementation

Software

- IEC 62304 and IEC 80002-1 implementation (software development life-cycle and risk management processes)
- medical device software validation

Medical electrical equipment

- adaptation or development of a medical electrical equipment compliant with IEC 60601 series of standards (2nd or 3rd edition)

- Medical device registration in Brazil – Anvisa specific solutions

- development of Anvisa registration regulatory strategy for your device
- Anvisa medical device registration
- RDC 59/2000 (brazilian GMP) implementation
- RDC 59/2000 “gap analysis”
- development and management of a RDC 59 internal audit program
- RDC 67/2009 – Technovigilance implementation

Medical electrical equipment mandatory certification (INMETRO)
- management of the certification process
- Portaria INMETRO 350/2010 implementation

- Solutions specific to South America
- development of a device registration regulatory strategy for South American markets
- device registration in South American countries

- Solutions specific to Europe and CE Marking
- development of CE Marking regulatory strategy for your device
- technical file or design dossier
- adaptation to harmonized standards
- post market strategy development

- Solutions specific to other markets/regions – contact me!

These are just some of the services available from SQR Consulting. If there is anything you require that is not listed please don’t hesitate to contact me at marcelo @ sqrconsulting.com.br or using my Contact page.