UK & Ireland Quality, Environmental & Health and Safety Suite.
Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop.
Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop.
A source of information for Prosthetic & Orthotic Professionals.
This website focuses on the new Medical Device Regulation 2017/745 (MDR) for manufacturers of custom-made devices. This new Medical Device Regulation 2017/745 (MDR) will play a significant role of patient care providers that create products like prosthetics, orthotics or wheelchairs. Creating prosthesis or orthosis is patient specific and therefore requires special documents which this website can help provide as information or as a template. This website will not take over your responsibility or liability, but we can offer support to be compliant to the Medical Device Regulation 2017/745 (MDR).
UK & Ireland Quality Management Core Board.
The names and roles for the Quality Management Core Board for the UK and Ireland are as follows:
Andrew McLean: Sales & Marketing Director
Email: Andrew.mclean@ottobock.com
Russell Pizzey: Regulatory Affairs & QMS Manager
Email: Russell.pizzey@ottobock.com
Mohammed Waqaar: Quality Assurance & Environmental Systems Manager, PRRC (Article 15, MDR) UK
Email: Mohammed.waqaar@ottobock.com
Micheal Whelan: Systems Quality Manager, PRRC (Article 15, MDR) Ireland
Email: Michael.whelan@ottobock.com
Paul Meach: Health and Safety Manager, UK & Ireland
Email: Paul.meach@ottobock.com
URS Certificates.
URS Certificate: ISO 14001
URS Certificate: ISO 45001
URS Certificate: ISO 13485
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Helpful Links.
Here you can some helpful links to guide you through our resources and support.