Services
How can we help you?
Regulatory Advice
Preparation of regulatory strategies for commercialization and technical file preparation to meet regulatory.
Quality Management System
Establishment of the documented quality management system (QMS) to ISO 13485 and 21 CFR 820.
Audits
Executing internal quality audits or supplier quality audits, as well as, conducting gap analysis.
Have a product to get on the market?
We can help you bring your medical device products to the market. Let’s talk about how we can assist you.
