Quality and customer benefit come first.
We strive to deliver our services to the highest standard, meeting the expectations of our customers and fulfilling the statutory and internal requirements. We guarantee that the quality of services is sustainably assured by:
- Maintaining quality checks across the whole service chain
- Ensuring the quality of the service providers instructed by us on your behalf (e.g. suppliers and laboratories)
- Providing certification and validation services
- Continuously improving our processes and services, and our expertise
Taking account of the risks.
We support you in the manufacture of safe products by using a structured risk management system, directed towards the requirements of ISO 14971, Risk Management for Medical Devices. Quality-relevant decisions are always made on the basis of risk. We will gladly provide you with a risk policy, FMEA and Risk Management Report for your risk record.
Regulatory Compliance – Recognising and implementing the requirements.
We work with you to identify the customer-specific statutory and standards requirements relevant to your products and our services. We ensure that all our products and services meet the requirements with regard to safety, quality and effectiveness.