Surgical Face Masks, Surgical Gloves, Standalone Software and Apps

Imagine receiving amazing

quality legal advice and

assistance on your surgical 

masks or gloves from 

remarkable regulatory 

lawyers 

 

 

 

 

 

 

Our outstanding surgical face masks regulatory lawyers will advise and assist your company if you manufacture or intend to manufacture and/or supply surgical face masks or surgical gloves in the UK.

 

Unless your company is exempted from the regulations in order to make and supply surgical (medical) face masks or surgical gloves in the UK, intended to protect patients, the face masks must meet the design and safety requirements of the regulations and be CE marked.

 

In order to assist your company with an application, a regulatory lawyer will require a clinical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of your product in order to assist with the application. The data needs to adequately demonstrate that the product fulfills its intended purpose.

 

There are further regulatory requirements if the surgical masks are sterile.

 

Product Types

  • Gloves with ‘dual use’
  • Examination Gloves
  • Examination Gloves coated with an antimicrobial agent
  • Stand-alone software including apps
  • Sterile Surgical Gloves
  • Surgical Gloves
  • Surgical Gloves coated with an antimicrobial agent
  • Surgical Masks

 

 

 

 

 

Our Services

 

Application for regulatory approval
  • Preparation of Application for Regulatory Approval
    • Clinical Evaluation to demonstrate safety and performance
    • Clinical Investigation if there insufficient pre-existing evidence to demonstrate that the product conforms with the essential requirements of the law
    • Preparation of  Technical Documentation

Classification 

  • Classification of Products
Covid19 Exemption
  • Application for exemption due to Covid19

Claims

  • Substantiation of Claims
Conformity
  • Declaration of Conformity
  • Conformity Assessment Advice

CE Marking

  • CE Marking Compliance
Requirements for Labelling and Packaging
  • Labelling & Packaging Compliance Advice
Vigilance
  • Vigilance procedures
    • Post-market surveillance, corrective action and vigilance procedure

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Articles

 

 

Related Services

 

 

Testimonials


 DNA Diagnostics Centre

 

We really appreciated RT Coopers professional expertise regarding a project they assisted with. Detailed and structured feedback was crucial and very important to our innovative concept. I will definitely revert back to Rosanna and the team on other projects in the near future.’ Daniell Leigh, Director 

For more testimonials on Product Regulation
 

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