Medical Devices

Regulations for Medical Devices are evolving worldwide, increasing the complexities in managing global regulatory compliance. Artixio is supporting it's clients with end to end commercial opportunity assessment and commercialization of medical devices in global markets using integrated regulatory services.  

Regulatory Intelligence & Strategy

Planning for registration of medical device in a country or multiple countries require right regulatory strategy based on country specific documentation, quality and clinical data requirements. Artixio's regional experts and experienced medical device leaders can provide right guidance and strategy for global registration using, 

  • Device intellectual property assessment and competitor analysis 

  • Regional regulatory and documentation requirements as per device classification

  • Registration timelines and importation process to assess time to market 

  • Reimbursement requirements 

  • Labeling requirements 

  • GMP requirements

Medical Device Regulatory and Quality Affairs

Based on medical device registration strategy, Artixio is helping its clients with,

  • Device classification 

  • QMS review and regulatory assessment (ISO 13485, 21 CFR Part 820)

  • Technical Documentation Review 

  • Dossier Preparation 

  • Product Registration 

  • Response to Health Authority Queries

Technical and Medical Writing

We are supporting our clients with medical and technical writing for medical devices. The services include, 

  • Authoring Biological Evaluation Reports as per ISO 10993-1

  • Authoring Performance Evaluation Reports (PER)

  • Post Marketing Surveillance Reports 

  • Clinical Evaluation Reports

Authorized Agent / Legal Representation

With our global presence, necessary sanitary licenses and regional affiliates, Artixio is representing its clients to Health Authorities responsible for submission and response to health authority queries. As an authorized agent, we can support with, 

  • Legal representation before and after approval of products 

  • Health Authority Interactions 

  • Renewals and Annual Reports Submission 

  • Assistance with Distribution and Import of Devices 

  • Address safety concerns

Clinical Evaluation Reports

Artixio provides MDR compliant, comprehensive clinical evaluation of medical devices by seasoned medical devices clinical experts. Our clinical evaluation of medical devices comprises CERs, CEPs, literature review (Medline, Embase) and data synthesis by medical professionals.