Patient Guard Limited

Patient Guard Limited

Patient Guard offering clear concise precise Regulatory and Quality Assurance services to medical device companies to help them achieve compliance as smoothly as possible.

Patient Guard Limited provides clear guidance to Medical Device developers and manufacturers on what they need to do in becoming legally compliant with world wide Medical Device Regulations. We aim to be as precise and concise as possible, and hold our clients ‘hands’ through the process, so that the device is right first time round.

Here at Patient Guard we offer you a bespoke package deal, that we tailor to your business needs. Our Quality and Regulatory expects provide a FREE consultation to confirm what requirement you require, so don’t worry if you are just a start-up company, or SME, we will make sure you have everything you require to get you through to the other side without all those unexpected costs, or burden of having to employ someone. Some of services that we offer are:

Management review consultations
Internal audits
Supplier audits
Supplier quality agreements
Maintenance of standards
Notified body audits attendance and support
Biological evaluation report
Post market surveillance and vigilance activities
Transition to MDR
Regulatory and quality horizon scanning
ISO 14791 risk management
ISO 13485 documentation compilation and implementation
Technical file compilation
Provision of staff training QMS and regulatory awareness
Free AD HOC, advice via email and phone

+44 01253 966900
Office 5, Lancaster House, Amy Johnson Way,
United Kingdom

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