SGS offers ISO 13485 training and training in medical devices quality systems at general, auditor and quality professional levels. This service is available globally from local SGS medical devices offices.

Training on medical devices quality systems and ISO 13485 audits are often needed to help customers and consultants write or amend documented quality systems, train internal auditors, train supplier auditors and as an introduction to new members of the quality department. All training in these areas will be based on ISO 13485:2003 Medical devices – Quality management systems- Requirements for regulatory purposes but can additionally include the quality system requirements of the appropriate national or regional regulations.

Typical courses and their durations in this area may include:

• ISO 13485 Internal Auditor (2 days)
• ISO 9001 to Medical Devices Auditor Transition (2 days)
• Control of Suppliers and Own Brand Labeling
  (1 day)
• Additional QMS requirements in regulations such as 93/42/EEC, 98/79/EEC, FDA, CMDCAS, Hong Kong Regulations, Taiwan, Japan (and more)

Training in the area of medical devices quality management systems and auditing can be provided as public courses and as tailored in-house training and given by SGS experts in English and often your local language. SGS training by being both up to date and practical can speed up initial certification or regulatory approval and provide ongoing improvements to your products and processes. Checks on compliance can be achieved by an SGS gap analysis audit.