Few industries evolve as quickly as healthcare and the manufacturing of medical devices. Medical device design, manufacturing, and sales can all be significantly influenced by digital transformation, healthcare reform, technological advancements, and regulatory compliance issues. It's no surprise that medical device manufacturers are increasingly turning to consultants for assistance.

If you're a medical device equipment manufacturer thinking about hiring outside help for your next product or addressing a looming compliance issue, here are the major reasons why you should turn to Thomas Regulatory Resolutions (TRR). The agent acts as the communicator. The FDA must provide important information to foreign companies. We have specialist FDA Medical Device Consultant agents handling complaints and product-related issues.

Product Safety and CE Marking Assessment

Our highly trained staff will recognise the directives and standards applicable to your products and ensure that all necessary tests and assessments are carried out. We will raise areas of concern and provide advice on recommended changes. Finally, our staff will assist you in completing your agreement declaration and will advise you on how to apply the CE mark certification to your product. We Provide The Best FDA masks and PPE Consultant services to our customers.

Self Assessment

Our knowledgeable staff is well-versed in the directives and standards that apply to your product. As a result, the applicable directives require that a notified body be involved in the product evaluation.

Reviewing Certification

Our staff examines the certification and test data provided by your suppliers to ensure that it is relevant, complete, and up to date. This service is primarily intended for importers and distributors of consumer goods and electrical equipment who must provide evidence of agreement for the goods they sell.

PUWER Evaluation

We are advising you on the provision and use of work equipment regulations for existing machinery and equipment. It requires equipment to continue meeting its requirements. PUWER has requirements for Workplace equipment, Employees and self-employed individuals that use it, Employers, managers, supervisors, and others who have authority over work equipment.

Analyze the Control System

Our machinery experts are trained to perform functional safety analyses on machines and systems, which can assist you in navigating complex standards such as EN ISO 13849 and EN 62061.

Reasons to choose our EU CE Mark MDR Medical Device Consultant Services

We offer a variety of consulting services. We also have years of experience leading, developing and implementing actionable marketing and sales for a variety of businesses. However, many companies may need to prepare for compliance to organize their regulatory transformation strategies. We focus solely on delivering business results for our clients in all areas. We hold leadership positions in international industry and consulting and have a reputation based on delivering long-term benefits to our clients. We strive to achieve the best customer satisfaction in our EU CE Mark MDR Medical Device Consultant services.