Senior, hands-on quality and regulatory advisory for medtech and life science companies. We help you navigate EU MDR and IVDR, build ISO 13485 quality systems that hold up under audit, and turn compliance into a dependable route to market.
Talk to us about this serviceFrom building your first quality management system to resolving a notified body finding, our consulting work covers the quality and regulatory questions that most often stand between a medical device and its market. Every engagement is led by a senior practitioner, scoped around the few issues that will make the biggest difference, and backed by our own technology solutions where they add speed or insight.
Quality management systems built or rebuilt around how your organisation actually works, covering ISO 13485, EU MDR and IVDR, and other market requirements. From first set-up and certification to simplifying and digitalising a system that has grown unwieldy.
Focused recovery when things have slipped, whether that is CAPA and nonconformance backlogs, complaint handling, technical documentation gaps or audit findings. We find the real causes, fix them, and strengthen the process so the same problems do not come back.
Classification, conformity assessment routes and regulatory pathways for mature and emerging markets. We support you in working with notified bodies and authorities, from planning through to submission and approval.
Preparation for notified body, certification, unannounced and regulatory audits and inspections. Mock and internal audits led by a certified ISO 13485 Lead Auditor, support on the day, and clear, convincing responses to findings.
For manufacturers placing devices on the EU market, especially those based outside Europe: EU Authorised Representative services, PRRC services under EU MDR Article 15, and practical support to meet your EU obligations from within Europe.
Compliance and market access for a more circular medtech industry: refurbishment and remanufacturing of medical equipment, circular and eco-design, and sustainability standards and requirements including IEC 63077, ESPR and PPWR. We help you bring refurbished and sustainable products to market with confidence.
We start from your problem, not a predefined package. True to the quintile principle behind our name, we identify the vital few issues that drive most of your compliance risk and focus effort there first. You work directly with a senior practitioner throughout, and we build capability in your team as we go, so the improvements last after the engagement ends.
We review your documentation, processes and regulatory position, and talk to the people who run them. The output is a clear, prioritised picture of where you stand and what matters most.
Together we agree a practical plan: priorities, deliverables, owners and timelines that fit your resources and your regulatory deadlines. Scope and cost are agreed up front, with no surprises.
We do the work alongside your team, drafting, reviewing, investigating, training and coaching as needed. Progress is visible at every stage, with regular check-ins against the plan.
We verify that the outcomes have been achieved and are effective, then hand over complete documentation and know-how so your team can sustain the results independently.
Talk to us about your consulting needs — we would love to understand your challenges and explore how Quintalys can help.
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