DEVELOPMENT AND IMPLEMENTATION OF DSTU ISO
The company "Consulting service plus" offers services for the development and implementation of DSTU ISO.
Send a requestProcedure of development and implementation of DSTU ISO:
Availability of quality management system (QMS) is a mandatory requirement for domestic and foreign manufacturers for the following classes of medical devices:
- Medical devices Is (sterile), I with measuring functions, IIa, IIb, III classes, according to the technical regulations on medical devices;
- Reagents, calibrators and controls, which are included in the list "A" and "B" of the Technical Regulations of medical devices for in-vitro diagnostics, products for self-monitoring;
- All medical devices that fall under the scope of the Technical Regulation on Active Implantable Medical Devices.
- The profile national standard of medical device manufacturers is DSTU ISO 13485: 2005. QMS must be developed and implemented, certification of the system is not a mandatory requirement of the Technical Regulation and is performed at the request of the manufacturer. For domestic manufacturers who plan to export their products to the EU markets, the international standard ISO 13485 is mandatory.
Most often, the company already has a quality management system and it needs to be analyzed and improved to meet the requirements of DSTU ISO 13485.
We offer services:
- Diagnostics and analysis of the quality management system operating at the enterprise;
- Development of documentation: quality guidelines, standard operating procedures (SOP), instructions, procedures, policies, etc.
- Conducting staff training, namely:
- Internal audit of the QMS. ISO 19011 standard;
- Basics of quality management. ISO 13485 standard;
- Directives 93/42/EEC, 98/79/EEC, technical regulations of Ukraine;
- Risk management for medical devices, ISO 14971 standard;
- Implementation of a quality management system;
- Pre-certification audit.
- The budget for the development and implementation of DSTU ISO depends on several factors:
- Number of personnel involved in the production of medical devices at the enterprise;
- Availability of regulatory documentation at the enterprise (SOPs, orders for hiring employees, job descriptions, registers with an assessment of suppliers, work instructions (safety, electrical safety, fire safety), etc;
- Availability of other QMS at the enterprise (ISO 9001, Good Manufacturing Practice - GMP and others); List of products, production lines;
- Types of production operations performed in production.
High professionalism of our employees and long experience of the company in the field of registration and licensing of medical products allow us to find the optimal solution for the client in the field of costs and terms of execution, because we have our own accredited centers, laboratories and hospitals;
Advantages of working with us
Reliability
Professional experience of the company with a team of highly qualified specialists in their field. We combine our knowledge and experience, use connections and contacts in the field of medical products certification since 2003.
Work without intermediaries
Our specialists are directly involved in the preparation of all documents and interaction with the relevant state authorities.
Guarantees
We guarantee the result of timely provision of services and cost. Compliance with the principles of confidentiality when working with clients. Rich experience allows us to solve problems and find solutions in any situation.
Short terms of work execution
Prompt execution of documents.
We control the timing of work and the correctness of documents at all stages. An integrated approach.
2003
Year of foundation
420
Regular customers
35
International partners
Our clients
Answers to frequently asked questions
The list of documents submitted for the assessment of conformity to the requirements of the Technical Regulations.
✔ Power of attorney of the manufacturer to the authorized representative
✔ List of medical devices for conformity assessment
✔ Certificates of conformity of the manufacturer:
1. Certificate of compliance of the quality system with the requirements of EN ISO 13485.
2. Technical file on MV.
3. Product description.
5. Product classification.
6. Specification for the product.
7. Specification for materials and components.
8. Labels (primary and secondary packaging).
9. List of applicable standards.
10. Risk analysis.
11. Confirmation of compliance with the basic requirements ("checklist").
12. Process diagrams.
13. Information on packaging.
14. Confirmation of conformity of measurement accuracy (if applicable).
15. Declaration of conformity of the MV with the requirements of the Directive.
16. Instructions for use of MV.
17. Report on preclinical studies (evaluation).
18. Report on clinical trials.
19. Quality guidelines.
Conformity assessment with the involvement of the authorized body provides a choice of two options:
By assessing the quality management system of the production site (inspection), resulting in the issuance of a certificate of conformity assessment for a medical device for a period of 5 years, associated with a certificate for a quality management system for a period of 3 years.
By batch conformity assessment, which provides for the issuance of a certificate for a specific batch (supply) of medical devices as a result of examination of documentation and testing of product samples.
Medical products, that have undergone state registration, are included into the state register of medical equipment and medical products and is approved for use on the territory of Ukraine, the validity of the certificate on state registration of which is restricted or ends after July 1, 2015 – it is possible to deliver on the registration certificate until 01 July, 2017. Product certification is the conformity process of product quality standards, established by the legislation requirements in Ukraine. Certification is carried by specifically accredited organizations. Supporting documents are issued on the results of certification – certificates of conformity, declaration of conformity.
To obtain a certificate of conformity assessment for a period of 5 years it is necessary to:
✔ Obtain an authorized representative of the manufacturer in Ukraine, to perform all related legal formalities.
✔ Choose a combination of procedures, according to class, manufacturer’s documentation, and other factors.
✔ • Form a technical file as required by the relevant regulations; prepare the application form and a check-list.
✔ Select the authorized body for conformity assessment and to apply, pay for the work of the authority.
✔ Undergo the documentation expertise procedure to respond to the comments.
Finalize the object, date and plan of the inspection.
✔ Organize inspectors visit on production.
✔ Eliminate the comments received as a result of the inspection.
✔ Get a decree of the regulatory body on the quality management system of the production site.
✔ Get a certificate of conformity assessment of the medical product requirements of the Technical Regulations.
✔ Issue a declaration of conformity with the Technical Regulations.
✔ Apply conformity mark and the identification number of the regulatory body to the labeling of the medical product; make sure that the other requirements for labeling and instructions (user manual) comply with the requirements of the Technical Regulations and the currents legislation.
Declaration of conformity replaces the registration certificate at the customs clearance of medical products.
There is no such list as a separate document. However, technical regulations divide medical devices into classes according to the level of potential risk to the patient. According to the class, some medical devices are subject to a mandatory self-declaration procedure, and the rest are subject to the requirements for involvement of the designated conformity assessment bodies in conformity assessment for placing on the market in Ukraine.