Quality Management Systems

🡨 Clinical Evaluations Coaching 🡪

Expertise in Medical Device Quality Systems

Quality is at the heart of what we do at JReg. We specialise in guiding companies through the development, implementation, and maintenance of ISO 13485-compliant Quality Management Systems (QMS).

With decades of practical experience in quality assurance and regulatory affairs, our team will ensure your QMS is robust, efficient, and tailored to align with international medical device standards. Our consultants work closely with your teams to not only meet the minimum requirements but to embed a culture of quality throughout your organisation. By aligning compliance with your business goals, we will help you achieve regulatory approval and long-term operational excellence.

Tailored Solutions and Ongoing Support

JReg design bespoke frameworks tailored to your specific processes and compliance needs. We provide support for ISO 13485, ISO 9001, and MDSAP certifications as well as guidance with:

  • Design and development file (DDF)
  • Embedding risk management practices aligned with ISO 14971
  • Transitioning to an electronic QMS (eQMS)

Our services include:

  • Gap analysis
  • Corrective and preventive actions (CAPA)
  • Verification and validation
  • Supplier audits
  • Usability engineering documentation

We focus on creating systems that are not only audit-ready but also streamlined to save valuable resources for your core business operations.

Audit Readiness and Regulatory Confidence

Our consultants help organisations prepare for Notified Body assessments, FDA inspections, MDSAP audits, and unannounced audits, giving you the confidence to demonstrate safety, performance, and compliance in every market.

JReg provides both remote and onsite audit support, tailored to your organisation’s needs. Our audit team includes experienced professionals who have worked for Notified Bodies and regulatory organisations, bringing valuable insight into regulatory expectations and audit best practices. This enables us to help you prepare effectively, anticipate potential challenges, and approach audits with confidence.

We can also provide on-the-ground support during audits, helping your team communicate effectively with auditors and regulators, respond to questions efficiently, and manage any findings in a timely manner.

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Frequently Asked Questions

A QMS ensures that your medical devices consistently meet regulatory, safety, and customer requirements. It’s also a legal requirement for CE marking (under EU MDR), UKCA, ISO 13485 certification, and participation in MDSAP.

Yes. We can develop and implement a tailored Quality Management System that aligns with your business size, product type, and target markets. This includes SOPs, policies, work instructions, and records.

Absolutely. We can review, update, or improve your existing QMS documentation to ensure continued compliance with the latest regulatory standards or to prepare for upcoming audits.

We support ISO 13485, EU MDR and IVDR, UK regulations, FDA QSR, and MDSAP. We also help align your system with applicable guidance from global regulatory authorities.

Yes. Our certified Lead Auditors can conduct internal audits, supplier audits, and mock audits to prepare your organisation for external inspections or certification audits.

Yes. We can perform MDSAP gap assessments, update your documentation, and conduct audit readiness training tailored to the participating countries in your scope (e.g. US, Canada, Japan, Brazil, Australia).

Yes. Through our partnership with Cognidox, we offer flexible and scalable electronic QMS platforms to digitise your quality processes and documentation.

Yes. We offer customised training sessions on quality management principles, audit preparation, CAPA processes, document control, and more — tailored to your team’s roles.

We assess your product types, market strategy, company size, and internal capabilities, then design or adapt your QMS to be compliant but not overly burdensome — striking the right balance between structure and flexibility.

Contact us to arrange an initial consultation. We’ll review your current QMS (if you have one), understand your goals, and propose a solution that meets your regulatory and business needs.

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