MedTech
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.
MedTech
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
Reimbursement requirements
Regional regulatory and documentation requirements as per device classification
Labeling requirements
Registration timelines and importation process to
assess time to market
GMP requirements
Medical Device Regulatory and Quality Affairs
Based on medical device registration strategy, Artixio is helping its clients with,
QMS review and regulatory assessment (ISO 13485,
21 CFR Part 820)
Product Registration
Technical Documentation Review
Dossier Preparation
Response to Health Authority Queries
Device classification
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
Post Marketing Surveillance Reports
Authoring Performance Evaluation Reports (PER)
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
Assistance with Distribution and Import of Devices
Address safety concerns
Renewals and Annual Reports Submission
Health Authority Interactions ​
