Quality management system
Why to have QMS?
To implement and maintain a quality management system (QMS) is an essential condition of regulatory compliance for the entry to the majority of world markets.
At the same time an implemented QMS will help companies to improve and support business practices in both the pre- and post-market phases, like the design and development process, and your device safety in general.
We offer you the following QMS services:
- We will help you to determine the required scope of your QMS based on your business and marketing strategy
- If you already have a QMS, we will perform a gap assessment against the latest applicable requirements to evaluate the status of your QMS
- If you want to sell in US, we will implement or upgrade your QMS to be compliant with the FDA QS Regulation (21 CFR Part 820)
- If you want to sell in Canada and other participating territories, we will implement or upgrade your QMS to be compliance with the Medical Device Single Audit Program (MDSAP)
- If you want to sell in EU or other parts of the world, we will implement or upgrade your QMS to be compliant with the international standard ISO 13485
- We will represent you in contact your certification body/auditing organization/registrar, from the early implementation phase until successful certification, including hosting of audits and inspections
- We will support the set-up of your QMS processes, creation of your quality manual, standard operating procedures, templates, risk management according to ISO 14971, CAPA system, complaint and other QMS elements
- We will support you in the implementation of mitigations in response to previous audit/inspection findings
- We will perform internal audits, pre-audits and mock audits
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