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Hi, I am not able to understand when you say Quality audit, do you mean ISO 13485:2016 based QMS Audit? If yes, then it depends on your plan to transition to MDR. In case you have a plan to move to MDR before the audit (which is highly unlikely since your CE certificate expires in 2024), then they ...

Hi,  We do Health Canada consulting work starting from $150 per hour to $250 per hour based on the type of work. Quality assurance & MDSAP work is on the lower side of the price and clinical evaluation & regulatory writing is on the higher side.  Please email me for more details and I will be able ...

I am looking to hire a PER EU IVDR consultant - Part-time (40 Hours per month max) for a few months. Let me know if you know someone who is fit for this role.  Duties and Responsibilities: Expert in EU in-vitro diagnostic device (IVD) regulatory requirements and able to provide an advise ...

Hi Jin, I trust you are going great. We are a Medical Device Engineering outsourcing company with extensive experience in Product Design and Quality Assurance. I would like to let you know that we have helped Medical Device companies to reduce their product cost by more than 40% with value engineering ...

I agree with Richard. ------------------------------ Kuldeep Tyagi CEO Ghaziabad India ------------------------------