Maintain Compliance

Maintain with IVDeology

Regulatory compliance never stops, and as your trusted knowledge partner, the IVDeology team can continue to support your product compliance with Quality Audits, QMS Health Checks, Post-Market Surveillance and Regulatory Intelligence.

Maintain and Improve your Regulatory Compliance

Quality
Audits

IVDeology can perform Supplier and Internal Audits on your behalf, to ensure delivery of products or services that meet required specifications for Quality Assurance, Risk Management and Regulatory Compliance.

QMS Health
Check

Our Quality Management System Health Check ensure your organisation’s QMS is effective, compliant, and continuously improving, to enhance its ongoing support of your business objectives.

Post-Market
Surveillance

We offer comprehensive Post-Market Surveillance planning and implementation, to fulfill regulatory requirements and monitor real-world performance of your med-tech products.

Regulatory
Intelligence

IVDeology offers expert monitoring of regulatory changes for med-tech manufacturers, providing timely updates and strategic compliance guidance for our partner companies.

Quality Audits

Effective Supplier and Internal Audits go beyond simple compliance checking — they’re strategic tools that help ensure your supply chain supports your organisation’s overall objectives for quality, efficiency, and reliability. A comprehensive audit includes:

  • Quality management system evaluation
  • Production capability and capacity assessment
  • Process control and stability verification
  • Raw material and component quality verification
  • Staff competence and training assessment
  • Documentation and record-keeping review
  • Product testing and validation procedures
  • Corrective action effectiveness evaluation
  • Continuous improvement program assessment

QMS Health Check

QMS Health Check are ultimately about more than just finding problems—they’re strategic tools for organisational improvement and excellence that help maintain product and service quality. Our QMS Health Checks include:

  • Initial audit scope and objective definition
  • Document review and system evaluation
  • Process assessment and compliance verification
  • Staff interviews and competence evaluation
  • Production and service delivery observation
  • Quality control testing and verification
  • Non-conformance identification and classification
  • Corrective action planning and implementation
  • Management system effectiveness evaluation

Post-Market Surveillance

Post-Market Surveillance (PMS) is a critical regulatory requirement for med-tech manufacturers. IVDeology provides comprehensive PMS solutions that not only ensure compliance but also provide valuable insights into product performance and safety, including:

  • Development of PMS plans aligned with regulatory requirements
  • Establishment of data collection mechanisms and procedures
  • Systematic monitoring of product performance and safety
  • Trend analysis and performance indicator tracking
  • Vigilance reporting and management
  • Periodic safety update report (PSUR) preparation
  • Post-market performance follow-up planning and execution
  • Corrective and preventive action management

Regulatory Intelligence

Med-tech manufacturers who need to stay current with evolving regulatory requirements can access IVDeology’s Regulatory Intelligence services. For our partners, this provides crucial insights without the cost of dedicated in-house regulatory specialists. Our Regulatory Intelligence support ensures that:

  • Changes to regulations are identified quickly
  • Impact assessments are performed effectively
  • Compliance strategies are developed proactively
  • Implementation plans align with business objectives

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Customer Case Study: QMS and Technical File Development for CE Marking Compliance

Customer Overview

Based in the UK, this instrument manufacturer sought assistance to CE mark their instruments and accessories. We’ve been partnering with them since 2021, providing the expertise they needed to navigate regulatory requirements.

Challenge

The customer needed to expertise to be able to develop their intern Quality management system, they looked to us to also support with templates and personalising the system in a way that worked for their team and processes. Having worked with them for several year, they knew

IVDeology had internal expertise in building and maintaining bespoke Quality management systems. They also did not have the internal qualifications to appoint a PRRC.

Solution

Our collaboration began with the development of a Quality Management System (QMS). We supplied tailored templates and worked closely with their team to customise them for their specific needs.

We also supported the company through:

– Stage 1 and Stage 2 certification audits, ensuring smooth progress toward compliance.

– Technical file review including supporting their team over the space of 18 months to ensure full alignment with the IVDR requirements

– Essential documentation checks, technical file compilation and IVDR documentation generation

To maintain ongoing compliance, we continue to provide a Person Responsible for Regulatory Compliance (PRRC) service, ensuring the customer remains up to date with regulatory changes and requirements.

Results

This project is a great example of the multiple services and support we offer in building, maintaining and outsourcing across IVDeology, the company now have a buildable and compliant QMS, and their internal teams have gained integral understanding of it’s use and importance, as well as gaining IVDeology as a partner to support with future maintenance and acceleration of the system, whilst simultaneously having the security of us as their PRRC.

Case Study: Supporting Customer Transition to new legal manufacturer and Ensuring IVD compliance maintenance

Customer Overview

Our UK based reagent manufacturer became a subcontractor for COVID-19 lateral flow devices and stablished a new legal manufacturer  for supply to the GB market. IVDeology has been providing ongoing support to this customer since 2020.

Challenges

  • Compliance with Regulatory Standards: They required support in ensuring their subcontracted COVID assays complied with the IVDD and IVDR.
  • New IVD Manufacturing Facility: The legal manufacturer needed guidance on establishing a new ISO 13485-compliant QMS against IVD manufacturing.
  • Market Access Strategy: They also needed to define their market access strategy

Solution

IVDeology provided tailored solutions across multiple projects to support the transition of the customer and ensure continued regulatory compliance:

  • Maintenance and build: We reviewed Technical Files for the customers subcontracted COVID assays, raising any gaps.
  • QMS Development: We helped them build a comprehensive ISO 13485-compliant QMS and conducted a gap assessment
  • eQMS Implementation: We implemented an electronic QMS (eQMS) to streamline quality management and documentation.
  • Performance Evaluation Support: IVDeology provided IVDR Performance Evaluation templates and training, aligning them with the expected UK MDR 2002 performance evaluation requirements.
  • Regulatory Training and Support: We offered ongoing IVDR training, internal audit support, and QARA assistance, including support for the product transfer from the old subcontract manufacturer to the new.
  • Ongoing Support: IVDeology continues to provide regulatory support for this customer, helping them stay compliant with evolving regulations and ensuring their market access.

Results

  • COVID Assay Compliance: They successfully continued to sub-contract manufacture COVID assays for the GB market in compliance with the IVDD.
  • GDx Manufacturing Facility: They built and launched a new IVD manufacturing facility, now fully compliant with ISO 13485.
  • Regulatory Confidence: They now has a clear market access strategy and is well-prepared for the IVDR and upcoming updates to the UK MDR 2002.
  • Successful Transition to Legal Manufacturer
  • Future Preparedness: They are actively planning Design & Development (D&D) activities for new devices, incorporating IVDR performance evaluation requirements in preparation for UK MDR 2002 updates with our support

Case Study: Supporting GDx in IVD Compliance and Expansion

Customer Overview

Biotech, based in Surrey, UK, originally a reagent manufacturer, became a subcontractor for COVID-19 lateral flow devices. As the business grew, they launched a new entity, GDx, to serve as the legal manufacturer of IVDs for the GB market. IVDeology has been providing critical regulatory support since 2020.

Challenges

  • Ensuring compliance with IVDD and IVDR for subcontracted COVID assays.
  • Guiding GDx in establishing an ISO 13485-compliant QMS and navigating regulatory requirements.
  • Defining a clear market access strategy for GDx’s new IVD manufacturing operations.

Solution

IVDeology delivered a tailored set of services, including:

  • Compliance Reviews for Biotech’s COVID assays under IVDD and IVDR.
  • QMS Development for GDx, including a gap assessment and full ISO 13485 certification.
  • eQMS Implementation to streamline quality management processes.
  • Performance Evaluation Templates and IVDR training for GDx’s compliance.
  • Ongoing QARA Support, including internal audits and product transfer support from Biotech to GDx.

Results

  • GDx successfully continued subcontracting COVID assays for the GB market in compliance with the IVDD.
  • GDx became ISO 13485-certified and established a fully compliant IVD manufacturing facility.
  • Clear market access strategy developed, positioning GDx for long-term success in the IVD sector.

Customer Case Study: Maintaining customer compliance transitioning from IVDD to IVDR

Customer Overview

An IVD manufacturer sought support to transition their Class A and Class C products from IVDD to IVDR compliance. They needed assistance ensuring their QMS and technical documentation aligned with the new IVDR requirements.

Challenges

  • Transitioning a Class A instrument and Class C device to meet IVDR compliance.
  • Updating ISO 13485-compliant QMS procedures and creating new ones for IVDR compliance.
  • Developing a complete Performance Evaluation suite and Technical Files (TFs) for the IVDR transition.

Solution

IVDeology worked closely with the client to deliver tailored and cost effective solutions, including:

  • Gap analysis of the current ISO 13485 QMS against IVDR requirements.
  • Review of tech files for both the Class A instrument and Class C device.
  • Updating QMS procedures and creating new ones specific to IVDR.
  • First draft generation of full Performance Evaluation documents for Class A and Class C devices.
  • IVDR guidance for tech file generation and workshops/training on new IVDR requirements.

Reseults

  • Enabled the customer to keep the Class A instrument on the EU market by ensuring it met IVDR compliance.
  • Provided the necessary knowledge and skills for the client to maintain compliance as new devices were introduced.
  • Tailored solutions, including topic-specific training and workshops, allowed the customer to confidently navigate the IVDR transition.
  • Customer saved time by using IVDeology who can support with a full transition project, as well as upskilling the team with training and workshops to continue their work successfully beyond our help