Expand Healthcare Consulting  GmbH

Point of Care In Vitro Diagnostics Experts

Expand Healthcare Consulting GmbH

Point of Care In Vitro Diagnostics Experts

Quality & Regulatory Management

Expand can provide full regulatory service support

Quality & Regulatory Management

Expand can provide full regulatory service support

As the healthcare market expands and ever innovative technologies offers new but more complex benefits for patients, government also continue to update regulation to adjust to the situation.

Whether it is IVDR or FDA or other regulatory matters, our quality management and compliance experts can help you meet these challenges.

From ideation to market launch we can provide you a full service support, so that your product development, production and clinical validation are done efficiently and in a timely manner.

As the healthcare market expands and ever innovative technologies offers new but more complex benefits for patients, government also continue to update regulation to adjust to the situation.

Whether it is IVDR or FDA or other regulatory matters, our quality management and compliance experts can help you meet these challenges.

From ideation to market launch we can provide you a full service support, so that your product development, production and clinical validation are done efficiently and in a timely manner.

Regulations

Regulations

ISO Certification

CE Mark and IVDR

FDA Submission

Do you have a regulatory issue?

We can offer expert advice!