Medical Device CE Mark Consultant

Essential Services Of CE Certification Consultant

Necessary Services Of CE Marking Consultant

We have a well-experienced staff of expert engineers and significant knowledge and familiarity with the CE marking process. We have a wide knowledge of safety standards, product safety assessments, product design and the real-world issues faced by the manufacturing industries. Our CE Mark Consultant assists new medical device manufacturers to launch a new device into the EU market. Here are our high-quality consultancy services.

  • Product Safety And CE Marking Assessment
  • Our highly experienced staff will recognize the directives and standards related to your products and ensure all the essential tests and assessments are completed. We will make raising areas of concern and advice on recommended adjustments. Finally, our staffs help you to complete your declaration of agreement and advice you on how to apply the CE mark certification to your product.

  • Self Assessment
  •      Our experienced staffs provide detailed knowledge of the directives and           standards applicable to your product. So, the applicable directives state           that a notified body must be occupied in the assessment of the products.

  • Certification Review
  • Our staffs review the certification and test data offered by your suppliers to confirm that it is applicable, complete and up-to-date. This service is mostly suitable for importers and distributors of consumer goods and electrical equipment who are required and ensure that they have evidence of agreement for the goods they sell.

  • PUWER Assessment
  • We are guiding you to the provision and use of work equipment regulations for machinery and equipment already in service. It needs an equipment to continue complying with its requirements. PUWER has requirements for:
  • Equipment for use at work
  • Persons using it like employees and self-employed persons.
  • Any person having control over work equipment like employers, managers, supervisors, etc.

  • Control System Analysis
  • Our machinery experts are qualified in conducting a functional safety analysis of machines and systems and it can help you navigate complex standards such as EN ISO 13849 and EN 62061.

  • Technical File Compilation/Review
  • We also identify the content you may need for your technical files and help you to compile it. Our experienced staffs review your files and confirm whether they contain the information required by the directives.

These are the essential services of the CE certification consultant. These tips are very helpful for your products.