A robust Quality Management System (QMS) is the backbone of regulatory compliance for medical device manufacturers. Beyond being a regulatory requirement, an effective QMS provides the structure needed to design safe devices, control risk, manage change, and scale operations sustainably. For startups and growing SMEs, however, implementing a QMS can feel overwhelming – often perceived as bureaucratic, resource-heavy, or disconnected from day-to-day development and operational activities.
Our QMS consulting services are designed to change that perception. We help medical device companies implement quality systems that are compliant, efficient, and proportionate to their size and complexity. Whether you are building a QMS from the ground up, upgrading an existing system to meet new regulatory requirements, or preparing for inspection or certification, we provide hands-on support that turns quality into a business enabler rather than a bottleneck.
ISO 13485 is the internationally recognised standard for medical device quality management systems and forms the foundation for compliance in most global markets. We support clients with the design, implementation, and maintenance of an ISO 13485-compliant QMS tailored to their organisation, product portfolio, and stage of growth.
For early-stage companies, this may involve building a right-sized QMS from scratch – defining essential procedures, templates, and records without unnecessary complexity. For more established manufacturers, we support QMS upgrades, remediation activities, and preparation for certification audits. We have experience working with “hardcopy” documentation, e-QMS software systems, or hybrid systems. Our approach focuses on practicality and usability, ensuring your QMS is embedded into daily operations and understood by your team, rather than existing as a set of disconnected documents.
While ISO 13485 provides a strong foundation, the EU MDR introduces additional and more explicit quality system requirements that go beyond the standard. These include enhanced controls around clinical evaluation, post-market surveillance, vigilance, risk management, and economic operator oversight. For many companies transitioning from the MDD, these requirements represent a significant shift in both documentation and mindset.
We support clients in identifying and implementing the additional procedures and processes required to meet MDR expectations. This includes updating post-market surveillance systems, integrating post-market clinical follow-up (PMCF) into the QMS, strengthening risk management processes, and ensuring traceability across technical documentation and quality records. Our focus is on alignment — helping you integrate MDR-specific requirements into your existing QMS in a coherent and sustainable way, rather than creating parallel systems that are difficult to maintain.
For companies targeting the US market, compliance with FDA quality system requirements is essential. While the FDA has historically enforced the Quality System Regulation (21 CFR Part 820), the transition to the Quality Management System Regulation (QSMR) represents an important evolution, aligning FDA expectations more closely with ISO 13485.
We support clients in developing and adapting quality systems that meet current FDA requirements while positioning them for QSMR alignment. This includes gap assessments against FDA expectations, updates to procedures and records, and support with inspection readiness. We also help companies understand how FDA quality requirements intersect with design controls, registration, complaint handling, adverse event reporting, CAPA, and supplier management — all areas that commonly attract regulatory scrutiny during inspections.
Our goal is to help you build a quality system that supports FDA submissions, withstands inspection, and scales as your US presence grows.
The Medical Device Single Audit Program (MDSAP) enables manufacturers to demonstrate compliance with the quality system and regulatory requirements of multiple regulatory authorities through a single audit. For companies operating in or planning to enter – or already selling into – markets such as the US, Canada, Australia, Brazil, and/or Japan, MDSAP can offer significant long-term efficiencies – but preparation is key.
We support clients with MDSAP readiness assessments, implementation planning, and audit preparation. This includes mapping existing quality system processes against MDSAP requirements, addressing gaps across participating jurisdictions, and strengthening processes in high-risk areas such as management responsibility, measurement and improvement, and design and production controls.
For companies new to MDSAP, we provide structured guidance to demystify the process and ensure expectations are clear. For more mature organisations, we offer targeted support to improve audit outcomes, respond to non-conformities, and maintain ongoing compliance across multiple markets.
