Medical Devices and In-Vitro Diagnostics (IVD)
- Have you transitioned to EU MDR 2017/745 or EU IVDR 2017/746?
- Do you feel overwhelmed with managing your transition to MDR or IVDR?
- Are your Processes, Procedures and Work Instructions MDR compliant?
- Will your Quality Management System stand up to an MDR or IVDR Audit from your Notified Body?
- Are you confident that you will succeed through your MDR or IVDR transition to maintain your certification in scope and to continue selling your products across your customer markets?
- Do you need help you with CE UKCA Marking?
- NPD – do you need a Regulatory Road Map?
- Are you struggling with Device Classification Rules and need guidance?
- Do you need an independent review of Risk Management Studies and Product Technical Files
- Do you need help with CE UKCA Marking?
We can conduct a Gap Analysis and help compile technical documentation for all construction types and product classifications implementations of amendments to enable continued compliance to ISO 13485: 2016, ISO 14971: 2019 through product life cycle for SME to multi-national companies and QMS transition to Medical Device Regulation EU MDR 2017/745 and EU IVDR 2017/746.
We can act as your UK Authorised QARA Representative under Article 15 of the MDR and IVDR.
Contact QAEC Limited to see how we can help you