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?

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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.

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 Services

Our Compliance Assessment Process

Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.

Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.

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We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.

Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.

Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.

Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.

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)?

Expertise

Our team of regulatory experts is well-versed in global cosmetic packaging regulations and has a proven track record of ensuring compliance.

Customized Solutions

We understand that each cosmetic product packaging is unique. Our solutions are tailored to your specific needs.

Why Choose Elexes?

Efficiency

We work diligently to provide timely results, ensuring your products' packaging meets compliance requirements promptly.

Compliance Assurance

Our comprehensive assessments and recommendations help you maintain compliance and avoid potential legal issues.

Confidentiality

We handle your product and packaging information with the utmost confidentiality and adhere to strict privacy standards.

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