Each Medical Device Producer knows that his Design History Files serve as tickets for gaining access to foreign regulated markets, as decisive input for the application of sales certificates, as input for supply and quality audits made by key clients or quality organizations and is often a compulsory deliverable for OEM manufacturers.
The steady growth and increasing complexity of regulations in the global medical device market, worth approx €140 billion, has made the project and product development documentation an increasingly important strategic asset to the Medical Device Producers.
"Keeping a Design History File complete and consistent over time is far from trivial, a fact noticed by many players in the market", claims Karl-Johan Larsson, Marketing Director at Aligned AG. “Today, small and medium Medical Device firms are sometimes unable to enter regulated markets or even forced to abandon them simply due to the high knowledge and cost barriers posed by the complexity of regulations.”
“The large corporations have adhered to extensive quality programs to cope with the increased documentation burden at the price of high inefficiencies and suffering development timelines. There is strong consensus among these players that an un-proportionally large part of the Medical Device development work is spent on DHF documentation." - continues Mr. Larsson
"The current Design History File situation in many firms uncovers a strong need for a structured, automated DHF Management targeted to restore confidence and control, increase productivity and significantly cut development timelines. Aligned Elements is our solution to that problem.".
Aligned Elements, a dedicated system for managing Design History Files, integrate all significant parts of the DHF and includes:
- Requirement, specification, use-case and test-case management. Manage the complete back bone of the project documentation and keep track of all changes over the product life-time using a fine-grained revision history and base-line functionality.
- Traceability management. Multiple views and diagrams visualize traces between the items under Design Control. Changes are clearly highlighted to signalize potential damage to the DHF consistency.
- Consistency control. A large number of configurable validation rules detect inconsistencies within and between the items under Design Control and allows immediate assessments of the current project documentation state.
- Risk management. Using an FMEA approach to analyze and manage failure modes, hazards and create mitigations which are traced back to new requirements, specifications or test cases.
By supporting Design Reviews, Digital Signatures according to the X.509 standard, bi-directional Microsoft Word integration and User Management aligned with FDA QSR 21 CRF Part 11, all crucial DHF parts are brought into one application and consequentially allows Aligned Elements to provide exceptional transparency, consistency and control with minimal effort.
Aligned Elements V1.5 is available as of 13th April 2008
Aligned (aligned.ch) has set out to become the leading player for ensuring and documenting the compliance of products in highly regulated markets. We assist our clients in developing, manufacture and market regulatory compliant products with higher confidence, to lower costs and within shorter timeframes.
Our clients are users, manufacturers and suppliers in the medical device industry, companies who develop, manufacture, market and use products which are subject to regulatory guidelines such as the FDA Quality Systems Regulations, the EU In Vitro Diagnostic Directive and the EU Medical Device Directive.
Aligned was founded in 2006 with headquarters in Zurich, Switzerland.