Understanding medical device and in vitro diagnostic (IVD) regulations is no simple task.
It requires a comprehensive understanding of the entire product lifecycle, from feasibility assessment to effective life cycle management, while also integrating a robust quality management system into your business operations.
Helen George
At LFH Regulatory, we recognise the challenges of staying compliant with changing regulations. That’s why we offer tailor-made training solutions, both virtually and onsite, designed to meet the unique needs of your business. Our courses cover a spectrum of crucial areas, including
Our on-site training is structured to suit your convenience. Conducted at a location of your choice, it ensures that your team can engage in a meaningful way in a familiar setting. This option minimises disruption to your day-to-day operations.
Our training programmes cover a wide range of topics, including risk management, regulatory changes, ISO 13485, and the creation of technical documentation.
If you don’t see a course that meets your specific needs, please get in touch—we offer bespoke solutions tailored to your exact requirements.
Understanding, identifying, and mitigating risks are critical aspects of regulatory compliance in the medical device and IVD industry. Our risk management training provides:
Comprehensive Risk Assessment:
Learn to conduct thorough risk assessments tailored to the characteristics of medical devices and IVDs.
Risk Mitigation Strategies:
Develop strategies to effectively mitigate identified risks throughout the product lifecycle.
Regulatory Alignment:
Understand how risk management aligns with global regulatory requirements.
The ISO 13485 standard is fundamental for ensuring the quality and safety of medical devices. In our ISO 13485 training, participants gain:
In-Depth Standard Understanding:
Explore the requirements and intricacies of ISO 13485:2016.
Implementation Guidance:
Learn practical steps to implement ISO 13485 within your organisation.
Audit Preparation:
Understand how to prepare for ISO 13485 audits to ensure compliance.
Staying on top of regulatory changes is essential in a dynamic industry.
Our regulatory change training offers:
Current Regulatory Landscape:
Stay informed about the latest updates and shifts in global regulatory requirements.
Adaptation Strategies:
Develop strategies to adapt to regulatory changes without disrupting operations.
Proactive Compliance:
Expect regulatory shifts and proactively adjust your compliance strategies.
Effective technical documentation is a cornerstone of regulatory compliance.
In this course, participants learn:
Documentation Requirements:
Understand the specific documentation needed for regulatory approval.
Best Practices in Documentation Creation:
Learn techniques to create comprehensive, accurate, and compliant technical documentation.
Lifecycle Documentation Management:
Strategies for Maintaining and Updating Technical Files Throughout the Product Lifecycle.
At LFH Regulatory, we understand that no two organisations are the same, especially when it comes to regulatory challenges and training needs.
That’s why we offer bespoke training solutions tailored to meet your specific requirements.
Our team of experts works closely with you to develop and deliver training programmes that are fully aligned with your strategic goals and regulatory obligations.
With LFH Regulatory, you can trust that your training is not just fit for purpose, but meticulously designed to deliver exceptional results for your organisation.
Developing a team equipped with the right skills is crucial for success in the medical device and IVD industries.
Our subject-matter experts ensure that your team gains insights directly relevant to their roles and responsibilities.
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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