Services

Quality System Implementation including:

• 21 CFR Part 820 (FDA Quality System Regulation)
• ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
• Canadian Medical Devices Regulation Part 1 (SOR 98/282)
• ISO 9001:2015, Quality management systems – Requirements
• COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
• MDR Regulation (EU) 2017/745 (replacing existing Medical Device Directive)

 

Gap analysis/transition plans for:

• ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
• ISO 9001:2015, Quality management systems – Requirements
• Regulation (EU) 2017/745 (replacing existing Medical Device Directive)

 

Internal Quality System Audits

 

Supplier Audits

 

Review quality system documentation

 

Quality System Training

 

MDSAP (Medical Device Single Audit Program) overview and preparation

 

On-site support during FDA inspections/registrar audits

 

Ongoing Quality Assurance Support

 

FDA 483 and Warning Letter responses and follow up actions