Patient Guard

Clear. Concise. Precise

MDR and IVDR Transition services

All medical devices placed on the EU marketplace after May 2020 will need to be compliant to the Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR). Compliance with the Medical Device Directives will no longer be acceptable.

Read More

Medical Device Risk Management

Risk Management is the underlying foundation that helps businesses quantify medical device risks that could impact the patient or medical team. It is a critical part of the medical device product development process.

Read More

Quality Management Service

All medical device manufacturers or ‘virtual manufacturers’ (Own Brand Labelling) are now required, under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), to have a Quality Management System in place.

Read More

Quality Management Representative

Medical Device Manufacturers that do not have a registered company address in the UK after Brexit will not be able to sell their products on the UK market unless they have an Authorised Quality Management Representative registered in the UK.

Read More

Qualified Person Service

The Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR) now include regulation on manufacturers having a Qualified Person.

Read More

ISO 13485 Implementation

If you do not have a quality management system in place, to help with your ISO 13485 implementation our consultants are here to help.

Read More

Biological Evaluation Report

Biological Evaluation is a very important part of your validation requirement for your medical device, make sure you get the right advice.

Read More

Clinical Evaluation Report

Clinical evidence has become much more important as part of the new regulations. It’s important that medical device manufacturers provide sufficient information to demonstrate that their devices are clinically safe.

Read More

Internal Audits Service

As part of ISO 13485 Quality Management Systems, it is a requirement for all internal audits to be performed on the systems processes and procedures, ensuring that the necessary standards are met. Any issues that arise should be corrected and actioned.

Read More

Supplier Audits Service

Many manufacturers of medical devices have subcontractors who perform critical parts of the device manufacturing or development process. These suppliers must be correctly managed to ensure that the quality of the device being developed or manufactured does not suffer, and complies with the agreements that the companies have in place.

Read More

FDA 510(k) Service

The US market can be a challenge for companies looking to sell their medical devices into the largest market in the world. They must engage with experts with the relevant knowledge and experience to ensure a smooth and efficient regulatory process.

Read More

Ready to discuss your project?