Services

The Quality Management Experts
in medical devices, life sciences and other complex technology projects

Perficio has developed the powerful but easy to use, web-based Q-perfect system which, with a little customisation, works with your existing processes. Q-perfect has been formally validated against EN ISO 13485:2016 and ISO 9001:2015, and can be deployed within weeks. Two training cycles are provided over an elapsed time of 8 weeks. Product development and project management practices may, however, take several project cycles to fully mature. Q-perfect provides a new culture to your company and should be seen as a strategic investment.

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Q-perfect Explained

The Q-perfect knowledge bank is a powerful set of process assets which maximise the efficiency of your team. Designed for ease of use, the Q-perfect record system maximises visibility and interaction between the management system and the broad community within the company. Q-perfect facilitates compliance through incorporation of management records into your company's daily business.

Q-perfect Innovation Environment

The Q-perfect innovation environment is an integrated product development and project management system. Product development features include requirements management and traceability, V&V tracking, design review, document review and approval. Q-perfect effortlessly manages the configuration of your product releases by tracking sub-system and module versions, associated document versions and associated requirements versions.

Project management features include project reporting, risk management, stakeholder management and communications, issues management and other PMBOK functions.

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How to Optimise your R & D Investment

Minimise your time to market and maximise your return on investment by avoiding rework, regulatory failures and process ambiguities. It is not uncommon for regulatory submissions to require multiple iterations before acceptance by regulatory agencies. Many of the product development processes are interlocutory. Omit one process and the integrity of your product and program may be at risk. The Q-perfect system enables your project team to operate within a compliant infrastructure and to progress through the product development cycle cognisant of the appropriate development pathways available to them. Q-perfect is the only management system integrating quality, project management and product development aspects into one coherent system.

Training

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Perficio can provide extensive training in every aspect of medical device development at the executive, managerial and operational levels. Exclusively developed by Perficio, the training modules have been created to satisfy the growing need in the industry for process-specific education. All the modules are theory/practical based and, through our highly interactive training approach, participants have the opportunity to discuss, deliberate, evaluate and acquire skills and knowledge.

Examples of the training modules we offer are:

· Medical Device Design and Development

· Design Control and Risk Management

· Project Management of Medical Devices

. Introduction to Process Validation

The Perficio trainers will carefully assess your specific needs and tailor the training systems to meet your goals: from brief, overview-type courses for multi-disciplined groups, through to comprehensive and highly detailed programs for small/specialised groups.