IVD Simplicity Ltd

medical devices

About

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 and customised solutions that are clear, no-nonsense and cost effective. Our services include: - 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.

Technologies

Google Cloud Hosting Mobile Friendly

Keywords

medical equipment manufacturing technical documentation review post-market vigilance cost-effective solutions risk management (iso 14971) post-market surveillance product lifecycle management ivd industry product design and development innovation product concept to market global ivd regulations regulatory gap analysis product classification regulatory pathway planning gap analysis mdsap global regulations eu ivdr compliance product classification uk mdr notified body audits consulting other scientific and technical consulting services regulatory submissions quality management systems regulatory compliance b2b iso 9001 performance evaluation planning feasibility assessment

Location

Manchester, England, United Kingdom

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