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Freyr provides regulatory strategy consulting services for medical device manufacturers looking for global expansion in complex markets like APAC, MENA & LATAM and supports in device registration, classification, assistance with notified body selection and regulatory submissions.
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Freyr provides regulatory support to the medical device manufacturers in De-Novo registration of medical devices in the USA that span across classification, Pre-Submission/Q-Submission meeting request, risk benefit determination, De-Novo submission package compilation, publishing and creation for Pre-Submissions.
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Freyr provides regulatory intelligence services for medical device manufacturers to meet region-specific health authority requirements for compliant market entry of their products and provides comprehensive regulatory Intelligence reports corresponding to organizational needs basing on the region and device type.
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Freyr provides medical device regulatory compliance, gap analysis and remediation services for medical device manufacturers that span across UDI, GDPR, EUDAMED compliance support, post approval compliance support, Consultation and representation services for ISO 13485:2016, MDSAP, BGMP and establishment of QMS document
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Freyr provides labeling and promotional material regulations support for medical devices manufacturers, which include creation & review of IFU (Instructions for Use), UDI compliance, GAP analysis, comprehensive artwork check, tracking and maintaining label changes.
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Freyr provides labeling services for medical device manufacturers that span across label creation, review of IFU (Instructions for Use), Gap analysis, UDI, EUDAMED & EU MDR label compliance, tracking and maintaining label changes as per regulatory requirements.
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Freyr provides regulatory support for medical device manufacturers in device technical file publishing, which include creation, review, validation, compilation and device technical file submission in electronic format to meet country specific health authority requirements for compliance.
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Freyr provides regulatory support for medical device manufacturers in preparation of Design History File (DHF) document, which include Design Plan, Design verification & validation, Risk Analysis, hazard identification and Human Factor Analysis to meet US FDA compliance requirements.
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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 helps In-Vitro Diagnostic Device (IVD) manufacturers in Performance Evaluation Report (PER) preparation, development of Performance Evaluation Plan, collecting & assessing the clinical evidence data, review and submission as per EU IVDR regulations for compliant market entry in Europe.
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Freyr provides Post Marketing Surveillance (PMS) support for medical device manufacturers, which includes development of PMS strategy, identifying the requirements to meet EU MDR standards, PMS data review, compilation and evaluating the data as per country specific compliance requirements.
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Freyr provides regulatory support for medical device manufacturers in preparation of Clinical Evaluation Report (CER), which includes report writing, GAP analysis, PMS data support for existing devices and updating CER as per EU MDR guidelines/regulations.
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Freyr provides medical device regulatory services in LATAM that span across medical device registration/notification, local representation support for compliant market entry
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Freyr provides medical device regulatory services in RoW Market that span across medical device registration, notification and local representation services for successful and compliant market entry of products.
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Freyr provides end-to-end regulatory services for medical devices manufacturers in Europe to comply with the new EU MDR regulations for successful market entry and also provides necessary Regulatory actions needed for the transition.
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Freyr provides regulatory support for medical device manufacturers in classification of their products as per the new European Medical device regulation (EU MDR)/In-vitro diagnostic regulation (IVDR) for product compliance.
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Freyr provides regulatory support for medical device manufacturers in 510k submission (510 k premarket notification) to USFDA, which include predicate device identification, 510k application compilation, gap analysis, publishing, creation & validation of e-copy, device listing for compliant market entry
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Freyr provides regulatory support for medical device manufacturers in 513 g submission, which includes medical device classification, preparation & review of 513g application and interaction with agency to comply with CDRH, FDA.
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Freyr acts as an authorized representative(AR) on behalf of the foreign medical device and In-Vitro Diagnostics (IVD) manufacturers in registration, pre-certification, post-approval, Marketing Authorization Holder (MAH) Services and also support for the Change of Legal Representative and Agency Interaction in Regional
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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.
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