Regulatory Requirements Register

ISO 13485:2016 requires your organisation to identify applicable regulatory requirements, document its regulatory roles (clause 4.1.1), include regulatory requirements in QMS documentation (clause 4.2.1 e)), and review new or revised requirements at Management Review (clause 5.6.2 l)).

What's Inside

• Regulatory Roles Summary
• Regulatory Requirements
• International / QMS
• European Union
• United States
• Singapore
• Malaysia
• Other Legal Requirements

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clauses 4.1.1, 4.2.1 and 5.6.2. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.