MedRAS Readiness tool

We have designed the MedRAS readiness tool as a quick, easy way for you to assess the readiness of your organisation, and as aid to help you identify how MedRAS can support your organisation and people.

The tool will present 5 core aspects of regulatory compliance which we use to gauge readiness of our organisations:

Registered place of business
Quality Management System
Technical file
Class of medical device
Resource

2 statements will be provided for each of these core aspects. You should read each statement, consider the current state of your organisation , and then select the statement you most agree with. The tool will analyse your response and return appropriate advice specific to the response you have provided.

Once completed, you can choose to print or save a copy of your responses for your own records/future reference. MedRAS will not store or retain a copy of your responses, and the tool is provided free of charge for the use of all. MedRAS provides consultancy and training services for the global medical device industry. Our specialists have Quality and regulatory expertise and experience working in and auditing compliance of medical device manufacturers and organisations to the following regulatory schemes:

MDD 93/42/EEC as amended
UK MDR 2002
MDR EU 2017/745
MDSAP (including any or all of the 5 MDSAP jurisdictions: Australia, Brazil, Canada, Japan, USA)
ISO 13485:2016

The readiness tool will help you determine how ready your organisation is regardless of the specific regulatory scheme(s) your organisation is seeking compliance for. For each core aspect, choose the statement which most accurately describes your organisation’s status:

Core aspect #1: Registered place of business

Core aspect #2: Quality Management System

Core aspect #3: Technical file

Core aspect #4: Class of medical device

Select the statement which is most relevant to your organisation's status.

Core aspect #5: Resource

Select the statement which is most relevant to your organisation's status.

Interpreting your results

In general, if you find you have chosen more A statements for the 5 core aspects, this indicates/suggests a better level of readiness for regulatory compliance. Selecting more B statements indicates your organisation may be in need for urgent support to achieve regulatory compliance. Whatever the outcomes presented by our tool, MedRAS is ready and able to provide the support your organisation needs to meet and overcome the increased regulatory burden, with cost effective tools and solutions. Find out more about MedRAS services by visiting our services page.

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