Company “Consulting service plus” has been working on the medical equipment market more than fourteen years.
We have the necessary knowledge, ability to carry out the whole spectrum of works on certification of medical products, disinfectants and cosmetics. We provide consulting services, text translation service, licensing and others.
We offer a range of services that allows minimizing of the financial costs and certification time.
Medical products certification:
- We organize the passage of a conformity assessment procedure approved by the Technical Regulations in the authorized bodies.
- We carry out examination of the dossier and make out a declaration of conformity on the self-declaration.
- We write and register Technical Specifications.
- We develop, implement and certify quality system at the enterprise in compliance with ISO 9001 and ISO 13485.
- We prepare and compile the technical file for the production.
- We develop a risk management file.
- We develop operational suitability file.
- We get the sanitary-epidemiological conclusion in the short term.
- We conduct clinical trials, specialized evaluation of clinical data.
- We organize writing to the customs authorities with proof of membership of medical devices.
Registration of disinfectants and cosmetics:
- We register disinfectants and cosmetics
- We get the sanitary-epidemiological conclusions for the disinfectants and cosmetics
- We register the instruction in the Ministry of Heath
- Obtaining a license for retail trade in medical products
- Obtaining a license for wholesale trade in medicinal products
- Renewal of the license for the wholesale / retail trade in medicinal products
- Obtaining a duplicate license
- Obtaining a license to practice medicine for legal entities
- Obtaining a license for medical practice for individual entrepreneurs
- Obtaining a license for turnover of drugs, psychotropic substances and precursors
- Translation of medical texts, notarization.
- “Authorized representative of the manufacturer” service.
- Declaration of wholesale prices of medicines and medical products.
- Organization of conferences/seminars.
- Organization of experts travel for certification: the formulation of visas, buying tickets, booking hotels.
- Obtaining the necessary documents as soon as possible.
- Organization and association of groups for travel that will save your costs.
- The optimal solution for the customer in terms of performance and costs, as we have our own accredited centers, laboratories and hospitals.
- For each client we have an individual approach to solving non-standard situations.
- High professionalism of our employees and the company's long experience in the field of registration and licensing of medical products allow you to quickly find a solution in case of dispute or difficult situations, as well as reduce the cost of implementation of the process by optimizing the passage of the necessary procedures.
We look forward to collaborating!