QAEC Limited

QAEC Limited is a UK Quality Assurance and Regulatory Affairs (QA/RA) consultancy supporting organisations across the Medical Device, In Vitro Diagnostics (IVD), MedTech, HealthTech, Biotech, Companion Diagnostics, Drug-Device Combination, and Manufacturing sectors. We work with clients from start-ups and university spinouts to SMEs and established global manufacturers. helping them successfully navigate complex regulatory frameworks across the UK, EU, USA, and international markets. Our team combines deep regulatory and quality expertise with a collaborative and practical approach, enabling clients to achieve and maintain compliance with global regulatory requirements. 💡 Our Expertise • All medical device classifications (Class I to III), including active, implantable, & Software as a Medical Device (SaMD) • UK MDR 2002 compliance & transition support • MDR 2017/745 compliance & transition support • IVDR 2017/746 compliance & transition support • Technical File & design documentation preparation, review, & remediation • CE & UKCA marking • Post-Market Surveillance (PMS) & vigilance reporting • US FDA regulatory strategy, submissions, & compliance • International regulatory strategy & notified body readiness • ISO 13485, MDSAP & ISO 9001 quality management system implementation & audit support • Verification & Validation (V&V) • Risk Management ISO 14971 • Support for UKAS-accredited laboratories aligned to ISO/IEC 17025 & ISO 9001. 🤝 Why Choose QAEC Limited? ✅ Proven experience – Global QA/RA expertise ensuring compliance with MDR, IVDR, FDA, CE, UKCA, & Post-Market Surveillance (PMS) requirements ✅ Collaborative, flexible support – Tailored consultancy delivered on-site or remotely, for short- or long-term needs ✅ Cost-effective – Expert QARA support cost-effectively ✅ Commitment to client success – We help your products meet regulatory expectations & achieve quality excellence. 🌐qaeclimited.co.uk | ✉️[email protected] | ☎+44 (0)1452 341913

• Employees 2
• Founded 2016