Medical Devices
Patient Guard provides all the knowledge and regulatory experience you will need to meet the hurdles associated when putting medical devices on the market and maintaining their compliance, whether you have an existing product, an enhanced model, or a completely new invention. You can make use of our knowledge to streamline the procedure and ease the burden of regulation on your company. Patient Guard has always supported medical equipment manufacturers across a variety of sectors. You can get assistance from our staff with any aspect of regulatory affairs and quality assurance. We all have experience working in the industry, so we understand how different from your regular job a regulatory project may be and the potential harm that time away from your regular operations can have on your firm.
Patient Guard works on regulatory matters in numerous jurisdictions daily; therefore, we are able to help at all levels and during the whole life of your medical device:
- Classification
- Identification of applicable standards
- Risk Management
- Technical File Creation
- Biological Evaluation Reports
- Clinical Evaluation Reports
- Registration Activities
- Post Market Surveillance Support
EU MDR Regulation (2017/745)
Patient Guard acknowledged right away that the Medical Devices Regulation (MDR) 2017/745, which replaced the Medical Device Directive, places substantially higher standards on medical device businesses (MDD). So that you don’t have to, we’ve worked hard to make sure we comprehend every nuance and the anticipated changes that businesses now face.
Patient Guard can handle all of your transition needs in moving your devices to the new MDR and we can influence and educate your team so they understand the key changes in regulation and related documentation, leaving your staff armed and your company ready for the future against the new regulatory landscape. This will help you understand how this affects you and your business.
We feel that we operate a little bit differently at Patient Guard. Regardless of size, we place a great deal of importance on our client relationships because we truly value the trust that our clients invest in us when they appoint us. As a result, we now frequently collaborate with repeat customers, and clients actually benefit from working with someone they are familiar with (and like), whose expertise is readily available to them.
We’re here to help you choose the best option for your medical device while keeping an eye on your budget as your go-to specialist in medical device regulation. So don’t hesitate to ask us for anything; we’ll figure out the most effective way to get it to you.
Also, if you’re not sure what you need, please get in touch with us so we can help.
Contact us right away at tel: +44(0)1253 966 900 or devices@patientguard.com to discuss your problem and learn how we can assist you in getting your items approved for sale
