Customized medical device solutions
Customized medical device solutions
In the dynamic and demanding world of medical device technology, a clear strategy is the key to success. Whether regulatory affairs (RA), quality management, information security (ISMS) or support for your R&D projects – I can help you meet the highest standards and turn your vision into reality.
Link to: Regulatory Affairs (RA) – Medical device regulatory requirements
Regulatory Affairs
Strategic planning and implementation to bring your products to market safely and compliantly.
Quality management
Efficient processes and systems that not only ensure, but also improve quality.
ISMS
Development and optimization of information security management systems to protect your data.
Technical documentation
High-level authoring and review – clear, accurate, and standards-compliant.
Link to: Audits in the medical device industry
Audits
Preparation, implementation and follow-up to meet audit challenges with ease.
eQM
Implement and optimize electronic quality management systems for seamless processes and compliance.
Integrated management systems
Efficient control of company processes and promotion of compliance with legal requirements.
Strategic consulting
Development of roadmaps that make your company fit for the future.
Shaping the future of medical technology together
Shaping the future of medical technology together
Together, we will find solutions that will not only convince you today, but will last tomorrow. Let’s take on the challenges of medical technology – with innovative approaches, sound expertise and a clear focus on your success.