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Quality management support
Project duration: 4 months
Brief description
In previous surveillance audits of the customer by its Notified Body, non-conformities were raised that the customer's process descriptions were partly outdated and did not meet the requirements of 93/42/EEC (MDD) and ISO 13485:2016. PTA supports the customer in processing and implementing non-conformities as required. This includes, on the one hand, translating standard operating procedures and work instructions into English and, on the other hand, checking whether the regulatory requirements from non-EU countries in which the customer's products are sold, exceed the requirements of the European requirements of 93/42/EEC (MDD) and ISO 13485.
Supplement
Standard operating procedures and work instructions have been translated into English in several areas, e.g. quality management handbook, quality management, document control, service, hygiene and health protection. The regulatory requirements of the following countries were examined to determine whether they exceed the European regulatory requirements: APAC (Australia, Singapore), LATAM (Argentina, Bolivia, Chile, Colombia, Mexico, Peru, Uruguay) and MENA (Iraq, Jordan, Saudi Arabia, Lebanon, Libya, Oman, United Arab Emirates).
Subject description
Manufacturers have to demonstrate that medical devices meet regulatory requirements and work as expected and predicted in order to market them. On one hand, manufacturers must establish a quality management system and document corresponding processes. On the other hand, they must maintain technical documentation for each product, which is a prerequisite for a medical device to be approved and registered. The approval and registration process and required contents of the technical documentation differ in detail for different countries.
Overview
- Industries medical technology
- Specialist tasks documentation, ISO 13485, MDD, medical devices, quality management, Regulatory affairs
- DV tasks IT consulting
- System environment organizational consulting
- Procedure model customer standard
Project period22.11.2018 - 30.03.2019
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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