Regulatory Compliance
Regulatory compliance is your responsibility.
Regulatory requirements vary widely by region and medical device. However, they all have one thing in common: the need for structured documentation of evidence of regulatory compliance. The focus is on the safety and performance of medical devices. We support you in reviewing and creating your technical documentation.
We are a reliable partner when it comes to identifying the regulatory requirements in different markets. We are happy to work with you to develop a strategy for regulatory approval and to evaluate your technical documentation.
You can count on us to document your technical documentation’s compliance with local requirements.
We have experience with approvals in Europe, North and South America, Asia (incl. China, India and Japan) as well as the Pacific and Gulf regions and South Africa.
Regulatory Compliance
Regulatory compliance is your responsibility.
Regulatory requirements vary widely by region and medical device. However, they all have one thing in common: the need for structured documentation of evidence of regulatory compliance. The focus is on the safety and performance of medical devices. We support you in reviewing and creating your technical documentation.
We are a reliable partner when it comes to identifying the regulatory requirements in different markets. We are happy to work with you to develop a strategy for regulatory approval and to evaluate your technical documentation.
You can count on us to document your technical documentation’s compliance with local requirements.
We have experience with approvals in Europe, North and South America, Asia (incl. China, India and Japan) as well as the Pacific and Gulf regions and South Africa.