Regulatory

No product, design or service will ever benefit anyone without first demonstrating compliance to regulations.

Regulatory compliance is not difficult if addressed early in the life of a project. Innovision has the knowledge and expertise to support, or lead, your efforts in all critical regulatory areas.

FDA and International Regulatory Compliance
  • Title 21 CFR
  • MDR (MDD to MDR conversion support)
  • ISO 9000 and ISO 9001
  • ISO 27001
  • SO 13485
  • ISO 14971
  • ISO 14001
  • Standards for implants for surgery, prosthetics and orthotics devices
  • OHSAS 18001 / ISO 45001
  • ISO 62304
  • IEC/TR 8002
  • ISO 15223
  • Standards for all Sterilization processes
  • IEC 60601
  • Human Factors Studies / Human Factors Engineering
  • Standards for implants for surgery (bone and joint replacements
  • Standards for hospital equipment
  • MDSAP Support / Mock Audits
  • Supplier Quality Audits
Submissions
  • US, EU, Health Canada, Australia and New Zealand
  • Class I, Class II, Class III, Class IV
  • PMA
  • 510(k)
  • Technical File
  • Design Dossier
  • Combination Products
  • Active Medical Devices