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Medical Device Consultancy

With decades of medical device and IVD expertise, our experienced consultants can assist you with your quality and regulatory challenges.

We offer multiple services related to design, manufacture and distribution of medical devices, IVD’s and combination devices. 

Your Partner 

We have a customer first approach to consulting, aiming to become a valuable partner through our simple and approachable style.

Practical 

At Leap we take a solution focused approach. Simplifying regulatory and quality challenges in a practical and sustainable way.

Consultancy Services:

 Regulatory strategy
 Technical file documentation review and creation
 Risk Management & ISO 14971 Implementation
 Medical Writing e.g. Clinical Evaluation Plans and Reports
 ISO 13485/ ISO 9001 QMS Implementation 
 Audits (Certified Lead Auditors)
 Training process and systems design and implementation
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Frequently asked questions

Do you have consultants in different countries?

Yes! We have a highly experienced professionals available to you in locations all over the world. 

Do you charge for initial consultations? 

No, there is no charge for the first consultation call. The first call is there to get an understanding of the work involved. We will only take on the work if we feel we have the right experience and expertise to deliver your desired outcomes. 

How can we be sure of the quality of the consultants?

We happily stand over the quality of our consultants. Once a piece of work has been agreed we will supply you with consultant CV's and you can also avail of a chemistry call with any or all of the consultants involved.

How do I book a consultation?

You can book an appointment by contacting our team of consultants at info@leapcompliance.com