We aim to offer simple, clear and simple advice on all aspects of regulatory affairs within the IVD and medical device sector, this includes:
- European IVD requirements under IVD Directive (98/79/EC), transitioning to IVD Regulation (2017/746/EU)
- FDA 510(k) and PMA submission
- Health Canada
- Australia (TGA)
- South America including Brazil, Argentina, Mexico
- Rest of world
We can help guide you through the principles and potential solutions to ensure compliance to European, USFDA and Rest of World IVD regulations including:
- Quality Management System to ISO13485:2016 (MDSAP)
- Technical File (STED) creation, remediation and maintenance
- Risk Management (ISO 14971:2012)
- Post Market Surveillance
- Vigilance, non-conformance and CAPA
- IVD/MD Labelling including UDI
- Support for transitioning legacy products to the European IVDR and MDR and RoW
We provide tailored training solutions at your premises where we build a training experience specific to your company, but including our knowledge and understanding of the IVD and medical device industry.
Our current training packages include:
- EU IVD Regulation (for all levels from a top-level overview to focused workshops)
- ISO13485:2016 MDSAP
- *Risk Management ISO14971
- *IVDR transition planning
We provide training at competitive rates and provide all training material including an IVDR manual and presentation material.
We provide ongoing quality and regulatory support (person responsible for regulatory compliance) in all aspects of the day to day running of an IVD company. We can provide support during management reviews, auditing, vigilance or global submissions. While our focus is to provide this service to start-up and small business' which do not have on-site quality representatives, we can support any business.
In the event of a no-deal Brexit situation, there may be a requirement for non-UK companies to have a UK based Authorised Representative. IVDeology can support IVD companies who do not have the UK base or the skillset to perform the authorised representative activities.
Introducing the new IVDeology Mentoring Programme
We feel passionate about developing quality and regulatory professionals who have gained experience from different parts of the IVD industry. Our Springboard programme is a mentoring subscription service provided to IVD companies to assist in the development and growth of their employees.
We provide face to face workshops, discussion forums and online support to allow delegates to develop a rounded IVD quality and regulatory knowledge specific to the needs of their company and role.