Regulatory strategy and management

Medical device design and manufacturing compliance in international markets

Background

Lucid’s team effectively and efficiently supports regulatory compliance for medical device organisations and products.

In 2013 Lucid achieved quality management system accreditation to ISO 13485 - design of medical devices.  In 2016 our scope was extended to manufacturing.

Regular audit demonstrating organisational compliance to ISO 13485, associated standards, local regulation and guidance are legal prerequisites to supply medical devices in most of the world.

Daily experience navigating the complexity of compliance includes:

• Regulatory gap analysis.

• Implications for products with aesthetic, and health information purposes.

• Planning compliance pathways.

• Pathways for research and healthcare institution exemptions.

• Digital, physical, combination and IVD product certification.

• Engagement of local regulatory representatives.

• Design with optimum documentation.

• Planning in-vitro evaluation, testing, human factors and clinical  trials.

• Unique device identification.

• Complying to pre-production, manufacturing and post-market evidence requirements.

Discovery

Starting with the end in mind is critical to success as cost, scheduling and resource implications of compliance significantly influence the viability of value innovation, including:

• Evaluation of the implications for intended purpose and indications for use.

• Medical device classification rationale.

• Applicable standards and guidance.

• Risk management planning and reports.

Design

We provide ad-hoc and ongoing consultancy independently or complementing the work of experts in organisations with existing regulatory skills in house.

 Delivery

Lucid’s team supports evaluation, testing and audit for:

• Human factors engineering (usability).

• Biological safety.

• Disinfection and sterilisation.

• Electrical safety and EMC.

• Software.

• Health IT systems.

• Clinical evaluation (document review).

• Clinical investigation (human trials).

• Post-market surveillance and vigilance.

• Quality management systems.

Results

Working with Lucid’s design team, the breadth and depth of Lucid’s know-how in regulatory affairs can:

• Accelerate and de-risk product development.

• Reduce management of multiple subcontractors.

• Deliver state-of-the-art knowledge relating to associated regulation and guidance - including health IT systems and machinery regulation.