At LFH Regulatory, we understand that a robust Quality Management System (QMS) is the cornerstone of ensuring the quality, safety, and effectiveness of medical devices or IVD.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Laura Friedl-Hirst, MD
Ensuring quality is essential in the medical device industry.
Patient safety, regulatory compliance, and market success all hinge on the quality and consistency of your medical products. Our QMS solutions provide the structure, control, and effectiveness you need to achieve and maintain excellence. We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
ISO 13485:2016 is an internationally recognised standard that offers a robust framework for establishing and maintaining your quality management system for the UK and European markets. This standard is also recognised in other global markets, providing a strong foundation for achieving compliance and excellence.
For those targeting the US market, compliance with 21 CFR Part 820, known as the Quality System Regulation (QSR), is imperative.
It involves establishing and maintaining a quality system to ensure your medical device meets the applicable requirements and specifications. Our expertise in this area assists you in navigating the specific requirements of the FDA, ensuring your products can access the vast US market.
If you already have an established QMS, our Quality Management Review Pathway offers an effective means of enhancing its efficiency and compliance. This pathway includes:
Understanding your organisation’s unique infrastructure is pivotal to developing and implementing an effective QMS. Our QMS development process involves a thorough review of your operations, ensuring that your QMS seamlessly integrates with your day-to-day activities. Tailoring your QMS to your specific needs promotes efficiency, quality, safety, and reliability in your devices.
Maintaining Your QMS: Ongoing Support for Success
Once your QMS is implemented, ongoing support is essential to keep it current and compliant with applicable standards. Our support services include reviewing and updating procedures, conducting internal and supplier audits, managing non-conformances, implementing corrective and preventive actions, and handling complaints. We ensure that your QMS remains robust and adaptable.
Next Steps: Empowering Your Quality Management
At LFH Regulatory, we provide next-level support to facilitate systemic changes within your business from the ground up. Contact us today to discuss your requirements and learn more about how our QMS expertise can elevate the quality, safety, and compliance of your medical devices.
We recognise the critical importance of your QMS to your organisation, customers, patients, and regulatory agencies.
Whether you are navigating the complex UK and European markets or expanding your reach globally, our QMS expertise is tailored to meet your specific needs.
Clinical and performance evaluations are a vital step in validating the safety and efficacy of your medical devices or IVDs.
Understanding Medical Device and In Vitro Diagnostic (IVD) regulations is complex and requires a comprehensive understanding of the entire product lifecycle.
Want to stay up to date? Subscribe to our newsletter.
Simplify your path to compliance, reach out to our experts today!
© LFH Regulatory. All Rights Reserved.
