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- Configuration management to boost quality and efficiency
- Optimum preparation for permitting, certification and FDA compliance
- Full replicability across the entire lifecycle
ECR AG, a member company of exceet Group and a specialist for complex electronics, recently introduced the product lifecycle management (PLM) solution Polarion and is already using it live in development work.
As a first challenge, the new PLM solution was used to help develop a new wearable vital data monitor for a Swiss client, with a view to optimum preparation for FDA approval. This offers the client consistent, end-to-end and up-to-date documentation perfectly suited to the special requirements placed on medical products.
The highly flexible Polarion software enables custom configuration management for complex development projects. Simultaneously, it takes specific documentation requirements such as FDA standards into consideration. In this way, all the documentation the customer has to submit during the course of regulatory requirements and permitting or certification procedures can already be prepared in line with the respective criteria. Particularly for new developments that must satisfy a set of mandatory requirements for detailed and comprehensive documentation, a PLM solution is a valuable resource: It permits a more efficient project design and thus offers a faster road to project completion.
But the exceet experts aren't just using Polarion for their own development projects: They also offer the product lifecycle management system as a customer service. This will allow many small companies to optimize their own development activities without having to invest in a full-scale PLM solution of their own, along with all the know-how needed to fully exploit it.
Thanks to the high flexibility of Polarion, exceet can also use the PLM solution to process orders from clients using different tools: Data exchanges via common market standards are simple.
"Polarion is a state-of-the-art PLM solution in terms of optimum documentation and perfect preparation for requirements by FDA, European and other regulatory procedures", says Dan Negrea, Managing Director of ECR AG, in explaining the motivation for selecting the new solution. "That means we not only boost our own development quality: By paving the way through the approval and certification process, we also offer our customers a clear competitive benefit."
- Configuration management to boost quality and efficiency
- Optimum preparation for permitting, certification and FDA compliance
- Full replicability across the entire lifecycle
ECR AG, a member company of exceet Group and a specialist for complex electronics, recently introduced the product lifecycle management (PLM) solution Polarion and is already using it live in development work.
As a first challenge, the new PLM solution was used to help develop a new wearable vital data monitor for a Swiss client, with a view to optimum preparation for FDA approval. This offers the client consistent, end-to-end and up-to-date documentation perfectly suited to the special requirements placed on medical products.
The highly flexible Polarion software enables custom configuration management for complex development projects. Simultaneously, it takes specific documentation requirements such as FDA standards into consideration. In this way, all the documentation the customer has to submit during the course of regulatory requirements and permitting or certification procedures can already be prepared in line with the respective criteria. Particularly for new developments that must satisfy a set of mandatory requirements for detailed and comprehensive documentation, a PLM solution is a valuable resource: It permits a more efficient project design and thus offers a faster road to project completion.
But the exceet experts aren't just using Polarion for their own development projects: They also offer the product lifecycle management system as a customer service. This will allow many small companies to optimize their own development activities without having to invest in a full-scale PLM solution of their own, along with all the know-how needed to fully exploit it.
Thanks to the high flexibility of Polarion, exceet can also use the PLM solution to process orders from clients using different tools: Data exchanges via common market standards are simple.
"Polarion is a state-of-the-art PLM solution in terms of optimum documentation and perfect preparation for requirements by FDA, European and other regulatory procedures", says Dan Negrea, Managing Director of ECR AG, in explaining the motivation for selecting the new solution. "That means we not only boost our own development quality: By paving the way through the approval and certification process, we also offer our customers a clear competitive benefit."
