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Regulatory Compliance,
Gap Analysis & Remediation

Overview

Overview

The Regulatory supervision in Medical Devices and diagnostics industries is expanding as the regional Health Authorities and global regulators work to improve patient safety by minimizing the risk of device-related injuries and adverse events. To ensure compliance with medical device GMP requirements beforehand, it is required that compliant quality systems be in place and that employees in all facilities and at all levels are fully aware of and adhere to these quality systems. 

GMP requirements for Medical Devices vary for different countries. Main regulations or guidelines related to quality management systems are ISO 13485:2016 and 21 CFR 820. Manufacturers aiming to market the devices in the EU region must comply with ISO 13485:2016 requirements and obtain certification from a Notified Body. This certificate is mandatory to obtain CE marking of devices. Manufacturers with an intention to enter the U.S. market shall comply with 21 CFR 820 regulations. There are common Medical Device Regulatory compliance and certification programs, such as, MDSAP which are accepted by multiple Regulatory bodies including, the US FDA, Health Canada, TGA, PMDA, ANVISA, etc. Such certifications prove promising for the Manufacturers targeting multiple countries. Other countries have their own medical device quality management system requirements. However, majority of other countries accept the certificates issued by the reference countries.

Establishing Medical Device QMS systems that are compliant with Regulatory requirements of multiple Health Agencies is a great challenge for device manufacturers. It is further complicated in cases where the Contract Manufacturing Sites are involved and medical device compliance requirements for each stake holder varies in each country. 

Freyr’s expert Medical Device RA professionals assist the organizations by providing medical device GMP compliance services through support in establishing compliant quality management system, carryout medical device gap analysis or medical device assessment as mock audits, internal audits, training the resources, conducting Medical Device gap analysis of established Quality systems for compliance with current Regulatory requirements and finally handling remediation, so as to obtain medical device GMP compliance successfully. The GMP compliance services include, end-to-end support for GMP compliance Audit ready QMS systems for the manufacturer.

Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • Establishing of new or revamp of existing Quality Management System
  • On-site or virtual mock audits and assessments along with suggested remediation plan  
  • Onsite and online training of multi -functional stakeholders on QMS requirements
  • Establishment of QMS documents such as, quality policies, manuals, SMF, SoPs, etc.
  • Medical Device gap analysis of documents, such as, Design Controls (DHF), technical files/design dossiers, risk documents, validation documents, usability engineering reports, Clinical Evaluation Reports
  • Consultation and representation services for ISO 13485:2016, MDSAP, BGMP and other relevant QMS certifications 
  • Device test plans as per Regulatory requirements
  • Post approval Regulatory Compliance 
  • Consultation for addressal and remediation of audit observations, market complaints and non-conformities
  • Change management of QMS and device registrations 
  • Other GMP compliance services, including, UDI Compliance, GDPR Compliance, EUDAMED Compliance support
Advantages

Freyr Advantages

  • Cost-effective
  • Global network with experienced Medical Devices Regulatory Affairs professionals
  • End-to-end Medical Devices and diagnostics Regulatory compliance services  
  • Qualified team with experience on diversified Medical Devices and diagnostic categories
  • Support for region-specific and global device launches considering the involved Regulatory complexities
  • Strong relationship with different Health Authorities, competent authorities, certification bodies, notified bodies and testing laboratories
  • Structured approach to ensure quick market access
  • Capability to capture and track all Regulatory submission information, commitments, and tasks pertaining to new devices and device life cycle management
  • Tracking and management of Regulatory compliance, gap analysis and remediation for all phases of the Regulatory process, device life cycle, and submission process
  • Supports, manage and tracks Regulatory reporting, notifications and correspondences to fulfill Regulatory compliance, gap analysis and remediation