Your Medical Device Regulatory Estimate

Do you want an estimate for how much it will cost to bring your idea for a new medical device to market? Our Medical Device Regulatory tool will give you the information you need so you can make an informed decision on how to proceed. Plus, it's completely free!

How It Works

Simply complete the form providing basic information about your idea for a new medical device. Our calculator will then automatically give you an estimate of the regulatory costs involved to bring your idea to market. The whole process only takes a few minutes.

You will also receive a free guide created by our expert team that outlines the steps involved in getting your medical device to a stage where it is ready for regulatory approval.

Your Data – Your Intellectual Property – Your Privacy Guaranteed

We will need some very basic information about your idea for a medical device to provide you with a cost estimate. However, you won’t be asked for any commercially sensitive or protected information.

How We Use Your Data

You can trust us with your personal information.

Plus, your intellectual property remains yours at all times.

Please see our privacy policy for detailed information regarding our approach to your data.

In summary, your idea or anything else in relation to the information you give us, will never be shared with any third parties and it won't be used by us for any other purpose.

Please enter your details

What stage is your Medical Device at? (Costs associated with design, prototyping, and/or manufacturing are not included in this quotation)

CONCEPT/DESIGN, DEVELOPMENT PROTOTYPING PRODUCTION STEP (I.E. MANUFACTURE, DESIGN TRANSFER) CLINICAL TRIALS REGULATORY ASSISTANCE/APPROVAL

Which market are you interested in targeting? (Tick all that apply)

USA (FDA) EUROPEAN UNION (CE MARKING) CANADA (HEALTH CANADA)

How complex is the device?

Simple (eg) Syringe, Suture Moderately Simple (eg) – Urinary Catheter, drainage catheter Semi Complex (eg) Therapeutic Catheter Very Complex (eg) Structural Heart repair, embedded sensors

What packaging and conditioning is required for your device?

Aging conditioning and Packaging Testing T0.5 (6 month) incl transit testing Aging conditioning and Packaging Testing T2 (2 year) incl transit testing Aging conditioning and Packaging Testing T3 (3 year) incl transit testing

What is the nature of body contact?

External/Skin Minimally Invasive / In Body Orifice Surgically invasive Implant device

What is the duration of contact?

< 60 minutes < 24 hrs 24 Hours - 30 Days | Prolonged Exposure > 30 days | Permanent Contact

Sterilisation requirements

Full EtO Sterilisation (ISO:EN 1135:2014) Gamma Sterilisation (ISO:EN 11137-2:2015) Adoptive EtO Cycle (AAMI TIR28:2016) N/A

Medical Device Regulatory Estimate

Starting from

This quote was generated on Tuesday 31st of March 2020 02:49:17 PM

Here is the estimate to bring your medical device idea through the necessary regulatory steps so it is ready to commercialise. The reference number for this estimate is:

We have sent you an email with a summary of the estimate along with a guide that outlines the steps involved.

The calculation above is an estimate based on the information you have given us. To find out more, to discuss your idea with one of our engineers, or to get a comprehensive and personalised quote, please complete the form below.