Your Global Medical Device Regulations Guide

A clear, easy-to-fill checklist designed to enable a quick gap assessment of all ISO 13485:2016 requirements.

It includes an action tracker for the implementation phase, helping you keep on top of who is responsible, when it is due and the current status.

Key Benefits:

• Covers all ISO 13485:2016 requirements

• Very easy to use design

• Filter and sort per your needs

• Saves you many hours of work and potential mistakes

• Support your ISO 13485 implementation today

Format: Microsoft Excel (2010/2013/2016)

[No software install required. Customizable template you may freely use within your company!]

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement

The Medical Device Single Audit Program (MDSAP) requirements are complicated. How they relate to ISO 13485:2016 is complicated. Ease your alignment by using this specially-designed checklist.

Assess all requirements (and alignments) between ISO 13485:2016 and MDSAP in one single document. All country-specific requirements are included, providing a holistic overview.

It includes an action tracker for the implementation phase, helping you keep on top of who is responsible, when it is due and the current status.

Benefits:

• Easy to use, providing a simple view of everything you need

• Includes all country-specific requirements

• Filter and sort any way you require

• Over 400 hours have gone into developing and refining this checklist

• Ace your next MDSAP audit, using this powerful tool

Format: Microsoft Excel (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement

Classification form according to Annex VIII of MDR (EU) 2017/745.

Includes the complete Annex VIII (classification rules) of MDR EU2017/745 and helps to classify your devices. Just download and go.

Format:  Microsoft Word (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement

Compare MDR and IVDR side by side, chapter by chapter, to determine how the requirements align. This table has been designed to cut down on mistakes and confusion when comparing the regulations, providing an all-in-one view side-by-side. Quickly see where exactly the same requirements are aligned.

Benefits:

• Simple, clean design that is easy to follow

• Includes all relevant regulations that align between MDR and IVDR

• Start using it right away, today

Format: Microsoft Word (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement

Designed to support your conformity to Annex I of MDR 2017/745, this document contains a full table of MDR general safety and performance requirements as well as a list of Applicable Standards.

Designed to be easy to use and follow, the template will save you many hours, headaches and potential mistakes. 

This MDR GSPR checklist is a mandatory document, required during the evaluation of your conformity. The template provides an overview of all elements required to prove this compliance, and is required for all classes of products, including:

• Class I  /  Class Ir  /  Class Is  /  Class Im  /  Class IIa  /  Class IIb  /  Class III

• Custom-made devices

• Drug product with a Medical Device

The template will provide you the information you should have on your technical file and will give you some examples of what you should fill on it. In the case of questions you can still reach out by email.

Note: Previously, in MDD 93/42/EC, this was called the “Essential Requirements”

Benefits:

• Use the template for all your products

• Flexible word design, suitable to your organisation

• Over 500 hours have gone into the development and refinement of this template

• Includes table of applicable standards and all current GSPR

• Start using it right away, today

Format: Microsoft Word (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement

As part of the new MDR 2017/745 and IVDR 2017/746, “Economic Operators”, organisations involved in the importation and distribution of medical devices, are subject to new regulatory changes that affect their ability to conduct business within the European Economic Area (EU).

Although each economic operator is individually responsible for compliance with the new MDR requirements, operators must confirm that all previous operators in the distribution chain have also adhered to regulations.

Don’t make a mistake, don’t miss out on this.

Using this tool it is easy to evaluate your roles and responsibilities as Economic Operators, including; Manufacturer, Authorized Representative, Distributor and Importer.

It provides a clear overview of the requirements and which Economic Operators it applies to.

Save yourselves time and serious headaches by using a tool specifically for this purpose.

Benefits:

• Use the template for all your products

• Flexible, easy to use Excel design, quickly hide and sort as needed

• Countless hours have gone into the development and refinement of this template

• Start using it right away, today!

Format: Microsoft Excel (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement