Regulatory Framework Training

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Training Solutions for Medical Devices and IVD Regulations

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. 

Customised Training for Your Business Needs

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: 

Risk Management

Gain insights into identifying, assessing, and mitigating risks associated with medical devices and IVDs.

Regulatory Changes

Stay ahead of the curve by comprehending the latest updates and shifts in the regulatory landscape.

ISO 13485

Understand the requirements of the international standard for quality management systems in the medical device industry.

Creation of Technical Documentation:

Master the art of developing comprehensive technical documentation essential for regulatory compliance.

CONVENIENCE AND ACCESSIBILITY

Onsite Training

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.

Virtual Training

Ideal for teams spread across different locations, this model of training ensures consistent and accessible learning experiences.

Why Choose LFH Regulatory for Training?

Cost-Effective Solutions:
Training without the need for extensive travel, reducing costs associated with off-site programmes.
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Subject-Matter Experts:
Learn from professionals who have an in-depth understanding of the medical device and IVD industry.
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Confidentiality:
Onsite training guarantees a private environment for discussions, addressing your unique business challenges.
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OUR TRAINING COURSES

Risk Management Training

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.

ISO 13485 Training

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.

Regulatory Changes Training

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.

Creation of Technical Documentation Training

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.

Equip Your Team with Essential Skills Today

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.