MDR PoC
The MDR
(Medical Device Regulation)
The MDR specialized written for hospitals as an MDR
management system. Tailored to Point-of-Care (PoC) 3D Labs delivering 'custom-made devices'.
The legal MDR requirements summarized by our lawyers in an accessible manner.
The MDR management system as required by the EU MDR legislation.
Includes generation of unique MDR compliance statements and your full MDR policy manual.
MDR 'CUSTOM-MADE DEVICES'
(Medical Device Regulation)
Everything you need to work fully in line with the
'MDR custom-made devices' requirements for every point-of-care provider who plans, designs and produces
custom-made devices for patients.
WHAT IS INCLUDED IN THE MDR MANAGEMENT PORTAL:
1. All the law, focused on your work and your 3D Lab.
2. Explained and described in practical actions,
immediately applicable within your hospital.
3. Your policy as required by the MDR
4. Your procedures as required by the MDR
5. Demonstrable compliance with the law
6. Your quality management system
7. Your production management system
8. Your product registration
9. Your product traceability system
10. Your record of deviations and feedback
11. All necessary documents
12. Managing your own protocols
13. Record and track actions within your 3D Lab
14. Ongoing online help for questions about the law
(ticket system)
15. Everything online and always up to date
In short: a complete MDR management system.
4 SIMPLE STEPS TO THE MDR STATEMENT OF COMPLIANCE
1. Purchase the Waveland MDR Compliance Mangement System
Order your own Waveland (MDR) management sys-
tem via our online shop.
You will get instant access to the online portal and
your policies, procedures and registrations are prepared for you. Ready to read and use.
And implement in your organisation.
2. Implementing policies and procedures
All you have to do is fill in the specific details of your own organisation. The (MDR) management system then
automatically generates your quality manual.
Waveland lawyers keep your quality policy up to date:
Changes in laws or standards are processed
for you. Naturally, you will be notified if something changes in the legislation.
With the MDR manual at hand, you implement
policies and procedures in your Point-of-care 3D Lab. In your own way. After all, you have been doing your job well for years. The Waveland (MDR) management system
provides overview and records how you work.
You can follow the policies and procedures that your (MDR) management system has prepared for you.
3. Online and face-to-face personal (online) support
With Waveland's convenient online question and answer
system, you never have to wait long for a response. Use the 'Ask your question' button and you will get a short and concise answer.
Help with implementation: Qase3D
Qase3D helps you with the implemetation of this MDR compliance management system.
Qase3D will annually audit your system for/with you. (This is invoiced separately for the implementation and audit time only)
This secures your ongoing MDR compliance.
Legal compliance is an ongoing challenge after all. Waveland and Qase3D helps to keep your compliance up to date.
4. Your 3D Lab operates according to the MDR
You have your MDR management system in place and your compliance is maintained by remote audits. The hours spend on these audits will be separately invoiced.
Your compliance is demonstrable, up-to-date and always applicable in your daily work.
You and your staff know what the law requires. You can apply and record your specifics.
Waveland stores everything for you.
Your own MDR compliance statement is generated by your MDR compliance portal.
The system generates your legally required and constantly up to date 'MDR Compliance Policy manual.
THE MDR PORTAL HELPS YOU WORK ACCORDING TO THE LAW:
- The system generates your declaration of conformity (mandatory for
each product) - You will be contacted for personal support to implement and use the MDR portal in the most efficient way. (basic price personal support: €1500,- excluding VAT)
- Works for each hospital 3D (point-of-care) lab
- To be used with every custom-made device delivered
- The most advanced legal advice, delivered online with all necessary legal knowledge, managment abilities and on top of that personal support.
- Contact Waveland for the many other helpfull and easy to use compliance management portals that are available (like GDRP Privacy legislation and ISO standards etc...)
