Modular Design History File Management

Modular product design enables efficient reuse, lower costs and faster market access. Modular document management can achieve the same effect for Medical Device Development documentation.

Presented at the booth of
Aligned AG
Halle 2 / B 2045

Showcase (real application example)

Tecan is a leading global provider of clinical diagnostics instruments. With a long and proven track record, Tecan is well-known for its liquid handling robots, providing some of the most flexible diagnostic pipetting platforms available today.

By exploiting the flexibility of an open platform approach Tecan is able to create applications that matches emerging market needs by assembling existing modules into new powerful solutions.

Like all medical device manufacturers, Tecan is facingĀ a growing amount of regulations, demanding an ever increasing amount of regulatory documents to be created and maintained.

A large part of the regulatory challenge consists in getting the development documentation (including the Design History File) in place for market submission.

As new products and product versions are brought to the market, Tecan is facing a growing administrative effort to keep the Design History Files consistent and up-to-date.

With the objective of curbing slipping time-lines, Tecan decided to bring in Aligned Elements to assist the management of development documents. Aligned Elements is specifically developed to design control documentation and traceability, including requirements, specifications, risks and verifications/validation documentation.

As an alternative of having one monolithic, integral Design History File for every product, Tecan used Aligned Elements to document individual modules in separate...

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Tecan is a leading global provider of clinical diagnostics instruments. With a long and proven track record, Tecan is well-known for its liquid handling robots, providing some of the most flexible diagnostic pipetting platforms available today.

By exploiting the flexibility of an open platform approach Tecan is able to create applications that matches emerging market needs by assembling existing modules into new powerful solutions.

Like all medical device manufacturers, Tecan is facingĀ a growing amount of regulations, demanding an ever increasing amount of regulatory documents to be created and maintained.

A large part of the regulatory challenge consists in getting the development documentation (including the Design History File) in place for market submission.

As new products and product versions are brought to the market, Tecan is facing a growing administrative effort to keep the Design History Files consistent and up-to-date.

With the objective of curbing slipping time-lines, Tecan decided to bring in Aligned Elements to assist the management of development documents. Aligned Elements is specifically developed to design control documentation and traceability, including requirements, specifications, risks and verifications/validation documentation.

As an alternative of having one monolithic, integral Design History File for every product, Tecan used Aligned Elements to document individual modules in separate packages.

Aligned Elements permits each module to consist of a set of specifications, risk assessments and in some cases verifications inferred from a module; all including an over-all traceability and a complete, encapsulated audit trail.

For new products, Tecan manages to set up a large part of the product documentation with in hours by simply referring and tracing to DHF content in existing modules.

The high degree of reuse and the increased confidence in the Design History Files permits Tecan to focus on developing world class products instead of continuously treading through regulatory administration work.



Product groups

Quality control
    Software

Application

Instruments

Customer

Tecan Schweiz

Industry

Medical

Focus topic

Smart design & engineering

Gallery

Provider who helped realising this showcase

Aligned AG

Spending too much time on design documentation and traceability? We can help! Develop medical devices smarter and faster with Aligned Elements.

Halle 2 / B 2045

Your contact person at Aligned AG

Get in contact with:

Karl Larsson
Management board

Image of   Karl Larsson

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