Quality & Regulatory Consulting for Medical Device Companies
At QAEC Limited, we provide expert quality and regulatory medical device consultancy services to help medical device companies meet global compliance standards, giving you the support you need throughout the life cycle of your medical device.
We have successfully managed all medical device classifications from Class I to Class III, and whether you are bringing a new medical device to market or enhancing an existing device, we can support your medical device projects.
We will help ensure your devices safeguard patient safety, remain compliant and achieve their designed purpose and use.
OUR SERVICES
- Regulatory Strategy Analysis: Develop a tailored regulatory strategy analysis for your medical devices, ensuring a clear pathway to global market approval while meeting FDA, UK MDR and EU MDR, and other international regulations.
- Auditing: Comprehensive internal and external audits for critical suppliers to maintain and improve compliance standards.
- Gap Assessment: Conduct a comprehensive gap assessment to identify and address regulatory compliance gaps in your medical devices, ensuring alignment with global standards like ISO 13485, 21 CFR 820, UK MDR and EU MDR.
- CE and UKCA Marking: Achieve seamless CE and UKCA marking for your medical devices, ensuring compliance with EU and UK regulatory requirements for swift market access.
What we can offer:
- Medical Device Remediation: Implement effective remediation strategies for your medical devices to address compliance gaps, ensuring alignment with regulatory standards like 21 CFR 820, UK MDR, EU MDR, and ISO 13485.
- Conformity Assessments: Help ensure your medical devices meet all regulatory requirements through thorough conformity assessments, providing certification for global markets under CE, UKCA, and FDA standards.
- Medical Device Technical Files – Creation, review, remediation, maintenance and enhancements.
- Continuous Improvement Strategies: Help you enhance your organisation’s efficiency, reduce operational costs, and boost your overall success rate by helping ensure compliance and streamlining your processes.
- MDD to EU MDR 2017/745 Transition: Proven expertise and guidance, providing comprehensive support for compliance with the latest EU MDR requirements, including clinical evaluations, technical documentation, and post-market surveillance.
- MDD to UK MDR 2002 Transition: Proven expertise and guidance through UK-specific regulatory processes and standards to maintain UK market access.
- Regulatory Submissions: Complete assistance with FDA, CE and UKCA Marking and other global regulatory approvals for medical devices.
- Quality Management Systems (QMS): Implementation, remediation and auditing of QMS in line with ISO 13485, MDR, and global standards.
- Post-Market Compliance: Ongoing surveillance, PSUR (Periodic Safety Update Report), risk management, and regulatory updates to help ensure long-term success.
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 protected] to discuss how we can support your medical device projects, as we are your trusted partner in medical device consulting.
