R & d in controlled environment
quality Standard ISO13485 regulates the development of diagnostic tests in such a way that on outputs you receive not only technology, but also all documentation, necessary for registration of medical device in Roszdravnadzor and for obtain the CEcertificate.
we constantly interact with the customer to achieve the desired result in the shortest possible time and with the least costs. Below is an excerpt from the standard operating procedure R & d management.
medical device research and development process control procedure (fragment)
Process design and development is carried out under controlled conditions. All activities are planned and documented. Projects are checked for pre-agreed stages of work and are validated if it indispensably. R & d results are verified prior to transfer to production.
risk assessment Team assesses the need for conduct risk analysis for each R & d project. In the evaluation risks include the head of the quality management Department, representatives of administration and head of research and development or representative.
The following risk management methods can be used to assess risk factors:Preliminary analysis of operational safety (PHA)
- trial and error
- the Analysis of the nature and consequences of failures (FMEA)
- Method DEFI
- failure tree Analysis (FTA)
- prediction by Delphic method
Source data for R & d
Department Employees research and development and sales and marketing are responsible for determining customer needs and their documentation in theReport , which will serve as an input for R & d. the report should include the following data:
- requirements for features/functions / performance and security, etc.
- development Time
- detailed product requirements (quality standard, including requirements customer, reliability, legal and regulatory requirements and requirements for the life of the product)
- price benchmarks
R & d Input for the R & d Department must be approved by management department's. They can be transferred in any form, including technical sheets data, customer drawings and specifications, photos, samples, references standards, technology of production, the logs of the division research and development, etc. All documents constituting the introductory these tasks for the research and development Department should be registered in the project Log.
Analysis of research and development
Consideration R & d documents are carried out at the appropriate design stages and developed and implemented by key representatives of all involved departments and, as appropriate, at the appropriate stage is carried out by those persons who are responsible for coordination or management of preclinical and clinical studies, as well as other special personnel. The degree and frequency of inspections carried out by the division research and development, depends on the complexity and significance check the products/product, but the control participants conducted at least once at each stage/phase of development.
R & d Department Documentation
· > Documentation the R & d Department identifies products, including characteristics that affect safety, suitability for use, operation, reliability, and provide instructions for production (i.e. drawings, specifications, procedures, quality standards works, inspection procedures, etc.). Documentation is developed in terms that allow you to adequately assess the compliance of the input job requirements for the research and development Department.
- Technical specifications and order of product packaging and the markings also refer to the documentation, which the Department does.
- Accompanying documentation (i.e. calculations, risk analysis, test results, verification and validation protocols, etc.) are also included in the documentation research and development Department.
- Final the documentation contains or refers to admission criteria and provides identify Department documents that are critical to the proper the functioning of the products.
- All the documentation of the research and development Department is monitored competent staff and approved by the head of the Department permission to release.
the details of the procedure can be found in the office of our company.