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Lean Compliance / Regulatory requirements

Mastering complexity with innovation

The regulatory requirements for medical devices and other safety-critical products are growing all the time. This radically increases project complexity. Companies that achieve a short "time-to-compliance" in such an environment are clearly at an advantage.

Unser Spektrum im Bereich «Lean Compliance»:
  • Industry know-how coupled with implementation expertise: Our specialists are highly familiar with the regulatory requirements and standards. In interdisciplinary project teams, we develop turnkey solutions for you based on the Lean Compliance approach.   
  • Agile procedure models and proven tools: Thanks to our long-standing experience in product development, we have diverse documentation templates at our disposal. With our requirements engineering, risk management, and traceability methods and tools, we ensure a lean process - without compromising your strength in innovation.
  • Fully certified: We have all the necessary certifications and methods such as ISO 13485, ISO 14791, IEC 62304, IEC 62366, GMP, Lean Compliance, Lean FMEA and the certified, practice-oriented Zühlke MedSys process.

We support your project with a tailor-made, regulation-compliant process based on the Lean Compliance approach. We accompany you throughout the process, providing advice on the efficient implementation of your idea, minimizing complexity, and ensuring your product or service meets the regulatory requirements.

 

Your contact

Photo: Mr Amadeo Verges

Amadeo Verges

Business Solution Manager, Partner
Lean Compliance