A Quality Management System (QMS) is crucial for ensuring the quality, safety, and effectiveness of medical products. Our comprehensive services help you implement and maintain QMS compliant with ISO 13485 and MDSAP standards, facilitating global market access.
Why QMS Implementation Matters
A well-implemented QMS is the backbone of regulatory compliance, product quality, and patient safety. It provides the necessary framework to manage processes, ensure consistent product quality, and meet regulatory requirements across different markets.
Laura Friedl-Hirst, MD
Our team is well-versed and up to date on ISO 13485 and MDSAP requirements, ensuring your QMS meets all regulatory standards.
ISO 13485:2016 is an internationally recognised standard that provides the framework for establishing and maintaining your QMS.
We help you implement this standard to ensure compliance and excellence in the UK, Europe, and other global markets.
The Medical Device Single Audit Program (MDSAP) allows for a single audit to satisfy the requirements of multiple regulatory jurisdictions, including the United States, Canada, Brazil, Australia, and Japan.
We assist you in implementing MDSAP, which uses ISO 13485 as its foundation while incorporating country-specific requirements.
For those targeting the US market, compliance with the FDA’s Quality System Regulation (21 CFR Part 820) is essential.
We help you establish and maintain a quality system that meets these specific requirements, ensuring access to the US market.
In-depth analysis of your existing QMS.
Identification of non-conformities and proposed solutions.
Strategic planning to address gaps.
Execution of the plan to ensure QMS compliance.
We begin by understanding your organisation’s unique needs and infrastructure to develop an effective QMS that integrates seamlessly with your operations.
This tailored approach promotes efficiency, quality, safety, and reliability in your medical devices.
Once your QMS is implemented, ongoing support is crucial to keep it current and compliant. Our services include:
We ensure that your QMS remains robust and adaptable, meeting all regulatory requirements.
Our team is here to help.
Fill out the contact form below to get started and let us guide you through the complexities of QMS implementation with confidence.
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.
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