A Professional Consultant Ensuring ISO 13485 Compliance for your Medical Device.
ISO 13458 is the globally recognized standard for medical device quality management that was published on February 25, 2016.
The primary focus of ISO13485 was on quality management systems which is now used as a framework by all medical device regulatory programs including MDSAP.
What is ISO 13485 Standard?
The ISO 13485 standard provides a framework that is essential to demonstrate compliance to regulatory requirements. This standard is meant for manufacturers, designers, as well as suppliers in medical device industry. This framework while keeping medical device industry players compliant to regulations also mitigates the risks to stakeholders.
Our experts will help you identify insufficiencies, determine inspection readiness, and evaluate risks, smoothing the inspection process and providing a greater chance of successful inspection. We will conduct periodic internal audits to ensure compliance with all the applicable ISO standards, cGMPs and internal regulations. Be it short targeted internal audits or more sustainable assessments across the quality management system (QMS), we have experts who can conduct a thorough audit and come up with any compliance gap that needs to be worked on.
The basic goal behind ISO 13485 standard was to
Key elements of ISO 13485 Standard -
We help with:
ISO 13485 certification readiness
ISO 13485 surveillance or recertification audit readiness
Implementation of processes w.r.t. ISO 13485
Ensuring consistency between processes and practices
Our Compliance Assessment Process
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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