Freyr Medical Device QMS Remediation Services: An Overview
Medical device manufacturers are operating in a highly regulated and evolving landscape, driven by requirements such as EU MDR/IVDR QMS remediation, FDA QMSR remediation, and ISO 13485 QMS compliance. Organizations must ensure globally harmonized quality systems that support risk-based processes, traceability, and lifecycle compliance.
However, companies often face challenges such as outdated SOPs, fragmented documentation, and gaps identified across 21 CFR 820, FDA QMSR, and ISO 13485 assessments. Weak CAPA systems, inconsistent change control, and lack of alignment with MDSAP requirements further increase the risk of audit observations, compliance issues, and approval delays.
Freyr helps organizations address these challenges through comprehensive QMS remediation services for medical devices. Our expertise spans ISO 13485, FDA QMSR, SOP, and MDSAP remediation. With a structured, end-to-end approach, we enable organizations to achieve compliance, enhance audit readiness, and build scalable, inspection-ready QMS frameworks.
Freyr Medical Device QMS Remediation Services
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QMS Gap Assessment Services
- 21 CFR 820 gap assessment
- FDA QMSR gap assessment
- ISO 13485 gap analysis
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QMS Remediation Services
- FDA QMSR remediation
- ISO 13485 QMS remediation
- EU MDR QMS remediation & EU IVDR QMS remediation
- MDSAP remediation medical device
- SOP remediation medical device
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Implementation & Audit Support
- QMS audit remediation services
- Notified Body audit readiness medical device
- Pre-acquisition QMS due diligence medical device
- Training, governance, and audit support
Book a meeting with our experts today
- Schedule a call today
Why Partner with Freyr?
- Expertise in medical device QMS remediation
- Proven success with ISO 13485, FDA QSR, EU MDR, IVDR, and MDSAP
- Over 2,000 SOPs drafted and remediated
- 98% audit success rate
- Strong in QSR to QMSR transitions
- Scalable global QMS remediation support
Frequently Asked Questions
01. What is QMS remediation for medical devices?
QMS remediation for medical devices involves identifying and correcting gaps in an existing Quality Management System to align with global regulations such as FDA QMSR, ISO 13485, EU MDR, and EU IVDR. These medical device QMS remediations ensure compliant processes, updated documentation, and improved audit readiness throughout the product lifecycle.
02. When is QMS remediation required?
QMS remediation is required after audit findings, regulatory inspections, or during transitions such as QSR to QMSR transition. It is commonly triggered by gaps identified across 21 CFR 820, FDA QMSR, and ISO 13485 assessments, especially when legacy systems fail to meet current regulatory expectations.
03. What is Notified Body audit readiness for medical devices?
Ensuring readiness for a Notified Body audit in the medical device sector requires that Quality Management System (QMS) documentation and processes comply with EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) standards. This includes providing QMS audit remediation services, addressing gaps, and aligning with ISO 13485. These efforts help organizations minimize non-conformities and successfully pass regulatory audits.
04. What is FDA QMSR remediation?
FDA QMSR remediation focuses on aligning existing QMS frameworks with the updated FDA Quality Management System Regulation. It involves addressing gaps identified through FDA QMSR gap assessment and transitioning via QSR to QMSR transition, ensuring risk-based quality management and compliance with ISO 13485-aligned requirements.
05. How does MDSAP impact QMS remediation?
MDSAP requires organizations to align their Quality Management Systems with the standards of multiple regulatory authorities within a single audit framework. This process involves addressing gaps in procedures, documentation, and Corrective and Preventive Action (CAPA) systems to meet MDSAP requirements. By doing so, organizations can ensure global compliance and reduce the need for multiple country-specific audits.
06. What is SOP remediation in QMS?
Remediating medical device SOPs involves updating, restructuring, or creating standard operating procedures to align with regulatory requirements such as ISO 13485, FDA QMSR, and EU MDR. It ensures consistency across processes and supports effective implementation of QMS remediation strategies.
07. Why choose Freyr for QMS remediation services?
Freyr provides comprehensive remediation services for medical device Quality Management Systems (QMS). These services include gap analysis for ISO 13485, remediation for FDA QMSR, EU MDR QMS, EU IVDR QMS, and MDSAP compliance. With our expertise in Standard Operating Procedure (SOP) remediation and in transitioning from QSR to QMSR, Freyr ensures you are audit-ready and compliant.
Celebrating Customers Success
Medical Devices
Registration and LR Support
Global
Freyr has been an indispensable partner in achieving rapid global scalability for our Software as a Medical Device (SaMD) business. As a startup, acquiring expertise in worldwide regulations is cost-prohibitive. Freyr's competitive pricing and tailored services allowed us to get that expertise at a fraction of the cost of full-time resources. Their team's responsiveness and adaptability to project priorities have greatly facilitated our progress. We recommend Freyr to any company seeking expert guidance and support in the medical device Regulatory domain.
Arie Henkin
VP - Quality and Regulatory, Australia -based, Leading SaMD Company
Medical Devices
Swiss Rep Services
Japan and Switzerland
I genuinely enjoy my time working with Freyr, and I view them as a truly valuable asset and extension to my own team. They are dependable and accurate, and their pricing is competitive. Beyond that, I won’t hesitate to collaborate with Freyr again.
Darren Mansell
Regulatory Affairs Manager, UK-based, Global Medical Device Design and Manufacturing Company
Medical Devices
Registration and AR Services
Malaysia and Indonesia
Freyr provides a reliable service with expertise across many countries. I can rely upon Freyr to provide the information necessary to make an informed decision before entering a formal scope of work agreement. Once a project is underway, the Freyr team acts professionally to execute the work with excellent communication of progress.
Robert Menadue
Regulatory and Quality Assurance Manager, Australia-based, Medical Device Manufacturing and Distribution Company
Medical Devices
Registration and LR Services
Brazil
We are impressed with Freyr’s support in providing us with quick and well-detailed solutions to our queries. Freyr’s constant support to adapt to ever-changing Regulatory conditions while providing support with any additional queries we had in a timely manner has truly impressed us.
Sergey Burlov
Quality Manager, Russia-based, Innovative SaMD Company
Medical Devices
UKRP Support
UK
FREYR has accompanied us with the registration of several products on the UK market. They have always been quick to reply, attentive to our needs, a great source of Regulatory information and support. The price is reasonable compared with other similar service providers. We particularly appreciate the personalized quarterly and annual status reports that Freyr provides. When we call on FREYR, we know they will do their best to satisfy our needs, and that customer satisfaction is a priority.
