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Product Design Changes in the Regulated Environment

Creation of the program management blueprint for instrument development in three projects.

>> Thermo Fisher Scientific

Thermo Fisher Scientific – Scientific applications supplier

As the world's largest supplier of scientific applications, Thermo Fisher Scientific helps make the world healthier, cleaner and safer with a wide range of products developed in-house. A key factor in this is to continuously improve the quality of products and services and to ensure compliance with global regulations. This requires a strong process orientation in product development and often leads to a balancing act between rapid market availability and time-consuming approval procedures.

Product Design Changes in the Regulated Environment

Three instrument development projects will be implemented in one program to meet EMC, IEC61010-1, IEC 61010-2-120 and RoHS compliance. Submission of technical documentation to obtain a new declaration of conformity is part of the project scope, as well as design conversion and procurement of maintenance update kits to mitigate risks.

„Project management is always a challenge: working with different teams, different cultures, demanding targets for performance, quality and cost and often a balancing act to bring everything in harmony. With House of PM as our project management we were able to quickly focus our team on the goals, work as a team with courage and perseverance and book solid results. And along the way we were able to train our own team. A successful achievement - thank you!“

Dr. Brit Meier - Senior Director Research & Development Thermo Fisher Scientific

Our Contribution

Creation of the program management blueprint including sharpening of the respective project goals, stakeholder analysis and integration of missing stakeholders, reorganization of the meeting structure and adaptation of the document storage, increase in transparency through revised reports to the steering committee, escalation of delayed deliveries (machine parts, certification testing services), roll-out planning and implementation of all necessary activities worldwide including design and commissioning of the programming and configuration of an application for document management of the evidence of compliance activities from the service appointment on site at the customer.

Particularly challenging was the exact identification of the affected instruments incl. location and current customers (worldwide and dating back approx. 30 years), coordination of the areas to be involved (production, service, logistics, R&D) to ensure deliveries and to be able to implement the scope in a reasonable time.

Contact
Hauke-Thun.jpg

Hauke Thun
Managing Director

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