Regulatory Services

Scapa Healthcare provides in-house regulatory services for the design, development and manufacturing of Class I, II and III medical devices. Our regulatory team has experience in registering products for over 90 global markets and it operates out of all our locations.

Our team also provides complete product life cycle management to our global customers in the development of cosmetics and topical skin care products. 

Regulatory Services

Expertise in Medical Device

  • Technical files and design dossiers
    • CE file
    • Dossier audits
    • Gap assessments
  • Global market registration
    • New product launches
    • Geographic expansion
  • Post market surveillance
    • Reporting clinical experience

Expertise in Cosmetics & Topical Skin Care

  • Lab testing
  • Safety testing
    • In-vitro and in-vivo
  • Primary research
  • Filing patents
  • 510(k)s filing
  • Clinical testing
    • For claim substantiations
  • Stability studies

 

 

Quality Management

Quality is in everything we do, from expert support, advice and concept design, through full-scale production.

  • Quality management to ISO 13485