At QAEC Limited, we provide expert quality and regulatory consultancy services to MedTech and HealthTech companies across the life science industry, covering all types of products. From medical devices and diagnostics to digital health and wearables, we help ensure your products comply with global regulatory standards, including FDA, CE Marking, and ISO 13485. Our tailored approach helps streamline the path to market approval while maintaining the highest quality standards.

Our Services

• Regulatory Strategy & Submissions: Expert guidance for FDA, CE UKCA Marking, and global approvals.
• Quality Management Systems (QMS): Design, implementation, and auditing of QMS in line with ISO 13485 and other global standards.
• Digital Health & Software as a Medical Device (SaMD): Compliance for, mobile apps, and digital health technologies.
• Clinical Evaluation: Conducting clinical evaluation reviews, ensuring compliance with global standards like EU MDR and FDA requirements.
• Post-Market Surveillance & Risk Management: Ongoing compliance monitoring, risk assessments, and vigilance reporting.

Why Choose Us?

• Proven expertise in medtech and healthtech regulatory compliance and quality management.
• Comprehensive quality and regulatory solutions for all MedTech and HealthTech products.
• End-to-end support, from development through post-market compliance.
• We offer a strategic approach and solutions.
• We are your trusted partner in MedTech and HealthTech.
• Our consultancy services are tailored to meet your needs at competitive and cost-effective rates.

Contact us today at +44 (0)1452 341913 or email us at enquiries@qaeclimited.co.uk to help ensure your MedTech and HealthTech products achieve global compliance and market success.

LET’S CONNECT

If you would like to find out more about our quality and regulatory consultancy services for your MedTech and HealthTech products, we are here to help.