Laura Friedl-Hirst, MD
At LFH Regulatory, our suite of medical writing services is designed to provide you with comprehensive support throughout your product’s lifecycle.
Our team of seasoned medical writers are well-versed in crafting documents that meet stringent regulatory requirements, ensuring that your message is communicated effectively and compliantly.
Our Services Include:
Clinical Evaluation is a critical ongoing component to collect, assess and analyse your clinical data to verify the safety and performance for its intended use.
At LFH Regulatory, we specialise in compiling Clinical Evaluation Reports (CERs) that not only meet applicable regulatory standards but also demonstrate that there is sufficient clinical evidence to verify the safety and performance of your device.
Clinical Investigation is a pivotal step in demonstrating the safety and effectiveness of medical devices. LFH Regulatory’s experts are skilled in planning, executing, and reporting on these investigations.
We have helped clients during the following stages of the investigation process:
Performance testing is a crucial step in ensuring the quality and reliability of IVDs.
LFH Regulatory can you assist you with the allocation of this testing. While we do not directly test devices ourselves, our extensive experience in the field equips us to guide you through this process and sure you document it correctly.
Our Performance Testing services include helping you allocate the following steps of your performance testing.
Laura Friedl-Hirst, MD
Performance Evaluation is required for any In Vitro Diagnostic (IVD) where you want to place your product on the EU market. Performance Evaluation Reports (PERs) are instrumental in highlighting your clinical evidence including your scientific validity, analytical and clinical performance data. LFH Regulatory excels in creating PERs that are comprehensive, compliant, and compelling.
Our PER service covers:
LFH Regulatory recognises the complex needs of medical device and IVD manufacturers. Our medical writing services are meticulously tailored to address the specific requirements of each category, ensuring that you receive documents that are not only accurate and compliant but also strategically positioned to support your market goals.
LFH Regulatory is your trusted partner for comprehensive and bespoke medical writing services. Our expertise, attention to detail, and commitment to regulatory compliance make us the preferred choice for manufacturers seeking top-tier medical writing support. For personalised assistance with your medical writing needs, please don’t hesitate to contact us.
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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