You have decided to implement a Quality Management System to comply with norms such as ISO13485 or ISO9001 but feel a bit lost? We can help to set things up rapidly with our set of templates.

You have already prepared procedures for your QMS or technical documentation for your medical device but not sure about the content? Let us help you with an in-depth review.

You are a startup active in the field of medical devices but do not have a dedicated person to act as a person responsible for regulatory compliance? We can provide this service for this mandatory role.

Software As a Medical Device is a category of medical device where the software is itself the medical device. The development of such type of software requires compliance with several standards and guidances. Qalisys can help you to find practical ways to develop your software in compliance with these requirements.

Computer System Validation (CSV) is an essential part of GxP and ISO compliance and must no be underestimated. We can help you with the definition of your validation strategy to meet compliance

You would like to increase your expertise regarding specific quality topics but have no internal experts available? Contact us for a specific training program.

KPIs are essential to monitor the efficiency of your quality management system. We can provide you with solutions to automate KPI management using PowerBI.

Your company lacks of resources to manage a Quality Management System? By outsourcing this activity to our company, we can provide you with an electronic QMS managed with modern validated tools (Scilife, Sharepoint...)