Rachael has spent the last decade in the life science industry and specialises in regulatory affairs, particularly for medical devices in the biomedical sector. Rachael is a graduate of the University of Edinburgh, and in 2010 completed the project management course Prince2.

She has extensive experience creating regulatory strategies for product development lifecycles. Rachael will be responsible for managing projects, the compilation of design history files, risk assessment, consulting with regulators and test houses (on behalf of our clients), gap analysis, and supporting the design of product packaging, labeling, and leaflets.

She will also join Andrew Chalmers in maintaining and continually improving upon i4pd’s ISO 9001 and ISO 13485 Quality Management Systems. Rachael joins the team in support of the continued expansion into medical and other regulated markets. With her previous experience implementing Medical Device Regulations (MDR) she has been hired to support the development and approval of new medical devices.

With the deadline for transitioning to the Medical Device Regulations fast approaching for products already on the market, Rachael will be working with manufacturers to undertake a gap analysis for this transition.

Support offered includes:

• Regulatory Strategy
• Gap Analysis
• Compilation of Technical File (for EU MDR Compliance)
• Device Labeling
• Instructions for Use
• General Safety Performance Requirements
• Risk Management Plan, Risk Assessment and Risk Management Report
• Biocompatibility Report & Material Specifications
• Software verification and Validation
• Notified Body Support (Submitting to, consulting with and answering from)

Would you be interested in receiving a budget for support in one or mare of these areas?

Schedule a no-obligation consultation with Rachel now