Efficacy
Medical Device Compliance

In English

Medical devices, combination products, MDR, MDD, GMP, compliance

COMPLIANCE AND Efficiency

Development and Manufacturing of Combination Products and Medical Devices

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Efficacy is founded and driven by Ole Overgaard who has more than 20 years of experience with combination products and medical devices.

Efficacy assists with obtaining compliance, effectiveness and efficiency in development and manufacturing of medical devices and combination products.

Efficacy operates best in the intersection between all the different stakeholders e.g. R&D, Production, QA, Regulatory Affairs, Clinical Affairs, etc. who all have their own language and priorities. We have extensive experience with development and manufacturing in GMP environments.

Services

  • Process Optimization: Optimizing the processes while respecting GMP

  • Quality Management Systems: Creating and maintaining an efficient and compliant Quality Management System

  • Handling of Documentation: Efficient handling of development documentation and manufacturing documentation

  • Participation in Projects: Effective and experienced participation in projects

Please contact us on the contacts page.