IVD Simplicity

Clear consulting. From concept to commercialisation.

IVD Simplicity

Clear, no-nonsense solutions

IVD Simplicity is dedicated to providing pragmatic, flexible and cost-effective consultancy and training services to start-ups and small companies within the IVD industry.

Through extensive experience gained within the field, we understand the array of challenges that start-ups and small companies face from product concept to commercialisation and beyond.

Our dynamic consultants use their technical expertise and experience to provide a range of regulatory, quality, product development and innovation solutions customised to the needs of your company.

Our services

We offer a broad range of flexible support, customised specifically to your needs.

Our services comprise:

• Regulatory consultancy, including product classification and regulatory strategy under the UK MDR, EU IVDR and other global regulations.

• Quality consultancy, including QMS implementation and maintenance.

• QMS auditing and gap analysis.

• Product design and development consultancy from initial concept to product commercialisation and post-market improvements.

• Innovation input to new product concepts.

• On-site group training covering regulatory, quality and product development requirements.

Why choose us?

The team at IVD Simplicity has extensive experience of working within start-up and small company environments which is why we aim to provide dynamic, hands-on and no-nonsense consulting and training services whilst always ensuring high-quality and cost-effective solutions.

Our consultants have developed their skills and expertise across a variety of disciplines within the IVD industry including, quality assurance, regulatory affairs, design and development, innovation, manufacturing and Notified Body auditing. Their credentials include the preparation and management of international regulatory submissions, QMS implementation and maintenance and the successful commercialisation of IVD products.

IVD Simplicity has a range of consulting and training services covering regulatory, quality, product development and innovation to support you from product concept to commercialisation and beyond. Whether you are a start-up or an established small company, we provide flexible and customised solutions that are clear, no-nonsense and cost-effective.

Clear consulting. From concept to commercialisation.

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