Medical Devices

Solutions for conformity in the design and development of medical devices

The manufacturers of medical devices nowadays confront very difficult challenges that include the demand of innovation, fulfillment of strict environmental and normative requirements in evolution, and contraction of prices, for not mentioning the intense competition that it is required minor time of launch of products to the market.

Such tasks as a historical file of the design to create, to generate links between requirements and product designs, to manage records CAPA, of non-conformity and complaints they can follow all directly in a system of integral development of products.

The equipments of engineering and development of the sector medical have to confront normative requirements, of management of quality, of times of delivery … The solutions of software are increasingly important in the design and help to the differentiation of the products, but the increasing volume and complexity are difficult to manage, given the multiple variants of products for different markets and opportunities.

The aim of this sector is clear: to manage and to simplify the conformity, increasing the productivity and the quality and to obtain, in turn, a visibility completes of the product.

Some of the competitive advantages that there will allow him the adoption of our solutions are:

  • To demonstrate the conformity in minutes by means of automatic generation of reports.
  • Integrate the management of risks, management of requirements, the design and the check and validation without difficulties, which allows the analysis of the impact of the changes with a simple click.
  • To provide an extendable and flexible solution adapted to manage the volume and the speed of the changes.
  • To reduce the time and the costs of development simultaneously that increases the quality of the product in his environment of collaborative development.

Our solutions provide a platform for the management of requirements that it will allow him:

  • To manage the changes of requirements.
  • To manage the configurations of requirements.
  • Traceability of requirements.
  • Creation of requirements.
  • To obtain visibility and metrics of requirements.
  • Collaboration in the chain of supply.
  • Architecture and administration.

Across our solutions and our know-how we will help him to reduce the complexity of the development of products with intensive use of software, allowing him to throw to the market more innovative products.

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