System Engineering
Inefficient product development processes lead to inefficient development projects and products that fail to satisfy market requirements.
The Perficio Product Development medical device product development process will simplify and accelerate your product development project and satisfy the regulatory requirements of your of your intended markets. The principal product development standards are ISO 13485 and 21 CFR 820.
The key feature of Perficio Product Development’s process is the establishment of product requirements at the commencement of your development project. This enables analysis of the ability of a potential design to satisfy key requirements, and to be compared with alternate and/or completing products. This key process ensures that the product design is optimal, and that your product has a competitive advantage. Development activities are focussed on the key requirements. Development effort is not wasted on satisfying requirements that do not add competitive value to the product.
The product requirements are the Design Inputs.
A deliverable of the development process is the specifications for your medical device. The specifications also include the manufacturing process and measurement or test methods and release criteria.
The product specifications are the Design Outputs.
Product performance is analysed to demonstrate that the design specifications are the correct specifications for your application, and your product conforms to these specifications. A number of Design of Experiment (DOE) analysis tools are available to assist with verification activities.
This analysis of product performance is the Design Verification.
Performance of the medical device, produced using initial/low volume production processes is tested, in its intended use environment, to confirm that the device satisfies the product requirements.
This field testing of product performance is the Design Validation.
The medical device is transferred from design team to manufacturing team and the device specifications are translated into production, distribution and installation specifications.
The documentation of production, distribution and installation specifications is the Device Master Record. The transfer from design to manufacturing is the Design Transfer.
The medical device design inputs, outputs, verification and validation activities must be formally documented.
The documentation of medical device design work is the Design History File.
Perficio Product Development can either, manage all aspects of your product development activities, assist your product development team, or provide training in product development to ensure you have an efficient compliant product development process.