QAEC Limited Revenue

About QAEC Limited

At QAEC Limited, we provide expert Quality Assurance and Regulatory Affairs consultancy services for the Medical Device, In Vitro Diagnostics (IVD), MedTech, HealthTech, BioTech, Pharma, and Manufacturing sectors. We work with a broad range of clients with diverse and innovative products, from university spin-outs and start-ups to SMEs and established global companies, helping them successfully navigate complex regulatory landscapes across the UK, EU, USA, and international markets. Our Expertise Includes: • All medical device classifications (Class I to Class III), including active, implantable, and Software as a Medical Device (SaMD). • In Vitro Diagnostics (IVDs) and other diagnostic technologies • EU MDR 2017/745 and IVDR 2017/746 transition, and UK MDR 2002 compliance. • CE and UKCA marking. • US FDA regulatory strategy, submissions, and compliance. • International regulatory strategy and notified body readiness. • ISO 13485 and ISO 9001 quality management system development, implementation and audit support. • Support for UKAS-accredited laboratories aligned to ISO/IEC 17025 and ISO 9001. Why Choose QAEC Limited? ✅ Proven track record – Global expertise in quality assurance and regulatory affairs for a variety of industries, ensuring global regulatory standards are met. ✅ Flexible, tailored support – from interim to long-term solutions. We handle projects of all sizes, from single assignments to full transitions or remediation programs, with specialist expertise available on-site or remotely. ✅ Cost-effective – our consultancy services are tailored to meet your needs at competitive rates. ✅ Dedicated to quality excellence and client success – commitment to quality excellence, ensuring your products not only meet regulatory standards but also set new benchmarks in healthcare quality. 🌐 Visit: https://qaeclimited.co.uk/ 📞 Book a free consultation today ✉️ Email: enquiries@qaeclimited.co.uk

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