QMS Setup & Implementation (ISO 13485, 9001, 9000)
QMS certification services for medical device companies & manufacturers
Quality management system (QMS) is one of the key components for any medical device company. As a medical device manufacturer you need to make sure that your device is safe for use. At Elexes Medical Consulting, we ensure that you have proper QMS in place, reducing any chance of compliance gap.
What is Quality Management System?
When it comes to medical device product development, design and manufacturing, QMS provides structured processes for all the aspects involved including - design, supplier control, personnel, control of records, clinical data, risk management, etc. The purpose of QMS is to improve the overall quality of the product while ensuring that it stays within the regulations.
For example, if we talk about global market like US and Europe, they have a specific set of standards that every medical device manufacturer must keep a check on. Like ISO 13485 standards and US FDA’s Quality system regulation i.e 21CFR part820 should be considered during the process.
We, being one of the trusted ISO 13485 medical consultant can help you follow and document all the applicable processes as per the regulations and standards.
Why is QMS important for a medical device company?
How can we help with Quality management system (QMS)?
As QMS certification consultant, we help you analyze the problems, issues and gaps within your process.
Our QMS certification consultants will help you with
Benefits of Quality Management System (QMS)
QMS is important to build trust as a medical device manufacturer since it
Our Compliance Assessment Process
Apart from FDA, EU, and Health Canada, we also provide medical device consulting services for India, Saudi Arabia, Australia, USA, South Africa & United Kingdom.
Wish to learn more about Quality management system (QMS)?
Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.
We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.
Why Choose Elexes?
We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.
Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.
We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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