We are always excited to meet you at such events and it is impressive how you always make an effort on expanding your business potential. But do you know, Regulatory compliances play a major role in having a hassle-free business and maximizing sales.
We don’t know if Regulatory Compliance is an issue for you, but if it is, we would love to schedule a brief meeting with you in any of the below events to learn more about how we can meet your Regulatory needs
27 January - 30 January 2025, Dubai World Trade Centre
At MAVEN, we are eager to meet you at "Arab Health", equipped with the expertise and tools necessary to help you achieve excellence in medical device certifications, including CE (EU MDR), US FDA (510k), UKCA, NIOSH, Indian MDR, ISO 13485, and MDSAP. With a proven track record of 100% client satisfaction, we look forward to bringing our commitment to excellence to your organization. Join us to stay informed on the latest advancements in regulatory compliance.
At MAVEN, we are ready to connect with you at "MEDICA", bringing our expertise and essential tools to help you achieve new heights in medical device compliance. Stay updated with the latest advancements in certifications, including CE (EU MDR), USFDA (510k), UKCA, NIOSH, Indian MDR, ISO 13485, and MDSAP. With a 100% client satisfaction rate, our commitment to excellence is proven, and we look forward to delivering the same exceptional service to your organization.
11 June - 13 June 2025, Miami Beach Convention Center, USA
We at MAVEN are excited to meet you at "FIME". As a leading medical device consultancy, we bring the expertise and tools necessary to help your organization achieve new heights in regulatory compliance. Our team specializes in certifications including CE (EU MDR), USFDA (510k), UKCA, NIOSH, Indian MDR, ISO 13485, and MDSAP. With a 100% client satisfaction rate, we are committed to delivering exceptional service tailored to your needs. We look forward to collaborating with you!
At MAVEN, we are ready to connect with you at "Hospitalar." Our team brings extensive expertise and essential tools to help your organization navigate the latest advancements in medical device certifications, including CE (EU MDR), USFDA (510k), UKCA, NIOSH, Indian MDR, ISO 13485, and MDSAP. With a 100% client satisfaction rate, we are committed to delivering exceptional service and helping you achieve new heights in compliance and regulatory excellence. We look forward to collaborating with you!
27 March - 29 March 2025, Hall 4 & 5, Pragati Maidan, New Delhi, India
We, at MAVEN, are excited to connect with you at "Medical Fair India." Our team is equipped with the expertise and tools necessary to help you navigate the latest advancements in medical device certifications, including CE (EU MDR), USFDA (510k), UKCA, NIOSH, Indian MDR, ISO 13485, and MDSAP. With a proven track record of 100% client satisfaction, we are committed to delivering exceptional service to your organization. Join us to explore how we can support your journey to regulatory success.
The technical file for medical devices refers to all the documents that a medical device manufacturer has to submit to NB or CA for review & approval for CE certification.
Clinical evaluation enables manufacturers to provide sufficient clinical evidence for demonstration of conformity of the device with the general safety and performance requirements.
In India, medical devices were regulated as drugs under the Drug and Cosmetic Act 1940. This concept has changed now, with publication on the Indian Medical Device rule 2017
For legal commercialization of your product, 510k approval process need to be carried out by choosing the type of 510k and complying to the requirements established by the USFDA
NIOSH must certify any respirator or respiratory protective product before it can be used in any workplace: medical, industrial, educational, etc. The regulation that empowers NIOSH to regulate and certify respiratory protective products is 42 CFR Part 84.
