Process Strategy
The core strategy of the process framework follows a “Safety-Based” approach, where development effort and complexity is safety concept-oriented. This approach is fully implemented for processes and the resulting work products. For each project using this framework, an individual reconciliation between the project and the customer development process must be done before starting the project (cooperation concept).
The development of a secure, stable and efficient medical device in alignment with regulatory laws, directives and legal requirements is the main objective of this framework, based on the following Medical Device Directives:
– 21 CFR 820
– EU-Directives 90/385/EWG
– EU-Directives 93/42/EWG
Excerpt of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices:
(a) ‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
– diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception,
– and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
– EU-Directives 98/79/EG
This process framework is a sample result of the process development service of PEDCO LIFECYCLE SERVICES https://www.pedco.eu/2.0/services/lifecycle-services/?lang=en
