Regulatory due diligence
Medical Device Regulatory Due Diligence
Our years of experience in medical device regulatory and quality consulting has given us unmatchable understanding of best medical device regulations to conduct thorough and detailed due diligence for your product.
We, at Elexes medical device consulting conduct thorough and effective due diligence for your product from the early development stage, helping you stay compliant which minimizing the risk and improving the chances of regulatory clearance.
Different due diligence services we offer
Our team of regulatory experts can help you review your product’s regulatory strategy while planning the right approval pathway for your product based on the regulatory body you wish to get approval for eg. UK CA, EU MDR/IVDR, US PMA/IDE/510(k). We have medical device regulatory consultants who will carry independent assessment of your device’s design as well as development process against the regulatory requirements, QMS primarily ISO 13485 Section 7.3 & 21 CFR 820.30.
Standards compliance assessment
Technical file and design history file review
Manufacturing due diligence
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.
Amazing Feedback Say About Services
CEO Masterlink, Arizona
CEO Novasignal, Los Angeles
President ViDava, Florida
Sr. Exe Treedental, Hong Kong
Manager Outset Medical, California
CTO Jana Care, Massachusetts
MD Blackrock Pharma, England
VP Regulatory AliveCor, California
Owner Liz Inc., Arizona
CEO Radformation, New York