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Freyr provides ISO 14971 Risk Management consulting services for medical device manufacturers that span across preparation of comprehensive remediation plan, gap analysis, development of ISO 14971 document and post-Market Surveillance support to ensure the safety and efficacy of medical devices.
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Freyr acts as a local authorized representative (AR) on behalf of foreign medical device manufacturers in registration and market entry of their products in ROW countries and acts as a single point of contact in the Country for liaison with Regulatory Agency.