Meet our Regulatory Affairs Specialist for MDR - Rachael Turkington

February 25, 2020

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

Posted in: ,

Latest News

Should I outsource my product design work?

This article provides an example budget range for each of the main costs associated with product development that you should consider in your overall budget.

i4pd secures Innovate UK funding to develop AI driven manufacturing cost estimator

i4pd is delighted to announce that it has been granted Innovate UK funding as part of the Manufacturing made smarter: digital supply chain, feasibility studies challenge.

Could These Inventions From Scotland's Universities Change Life As We Know It?

Academic entrepreneurs from across Scotland’s university sector are now through to the next stage of the Converge programme. Split across four challenge categories – Converge, Creative, Impact and KickStart.

It all starts with a conversation.
Let's make something amazing together.

We'd love to hear from you.
Book a Meeting

Leverage our #DesignInsights to shape your development.

Subscribe for our webinars, articles and reports.
Subscribe Now
logo i4pd
linkedin facebook pinterest youtube rss twitter instagram facebook-blank rss-blank linkedin-blank pinterest youtube twitter instagram