How to find MDR consultants for a small organization?

[Make it work]

Our tiny family business only has one device - a well established IIa medical device that is MDD and MDSAP certified. We passed our MDR QMS upgrade assessment last year but need help to comply with MDR technical requirements. We have been able to make it work but MDR is a challenge.

Also challenging is finding a consultant who can work with small companies. Any suggestions would be very appreciated. We are located in Seattle.

 

[Sidney Vianna]

Any suggestions would be very appreciated.

Even though a lot of work can be done remotely these days, it ALWAYS helps to inform WHERE the business is located at.

 

[Make it work]

Even though a lot of work can be done remotely these days, it ALWAYS helps to inform WHERE the business is located at.

Thank you! Good point. I've updated.

 

[Regulity]

Our tiny family business only has one device - a well established IIa medical device that is MDD and MDSAP certified. We passed our MDR QMS upgrade assessment last year but need help to comply with MDR technical requirements. We have been able to make it work but MDR is a challenge.

Also challenging is finding a consultant who can work with small companies. Any suggestions would be very appreciated. We are located in Seattle.

We believe our team is a strong fit for your requirements. We work exclusively with startups and have prior experience conducting gap assessments for transitions from EU MDD to MDR.

Based on this experience, the tasks involved in your case would be comparatively fewer than those required for a full EU MDR implementation.

We’d welcome the opportunity to discuss this further. Please feel free to share your thoughts or reach out to me directly at contact@qaramedtechsolutions.com

 

[Make it work]

We believe our team is a strong fit for your requirements. We work exclusively with startups and have prior experience conducting gap assessments for transitions from EU MDD to MDR.

Based on this experience, the tasks involved in your case would be comparatively fewer than those required for a full EU MDR implementation.

We’d welcome the opportunity to discuss this further. Please feel free to share your thoughts or reach out to me directly at contact@qaramedtechsolutions.com

Thank you for reaching out. We found a local consultant but things can still go sideways. I will keep your contact information.