Given that the the Regulatory is rapidly evolving and making it extremely difficult for medical device manufacturers to comply with these stringent regulations, it is easy to make mistakes and get involved with Regulatory Authorities. This can result in recalls, 483 letters, getting CE mark denied, or getting your product pulled off the market. Our industry experts stay up to date with the ever changing regulatory landscape and understand the regulations in extreme detail. 

With help of our resources we ensure speed to market by creating your 510k, CE mark applications, and ensure your path to regulatory approval. If you are having regulatory issues, our team can assist you with getting compliant with the regulations and put your product on market. 

510K & CE Mark Services

It is essential to receive regulatory approval from agencies prior to selling your products on market. Kite Medtech has partnered with several leading device manufacturers and provided them with following services:

• 510(k) Submissions
• Technical File/Design Dossier Gap Assessments
• Technical File/Design Dossier Remediation
• Letter to file (LTF) for changes to existing products
• US Agent Appointment 
• EU Authorized Rep
• Person Responsible for Regulatory Compliance(PRRC)
• PMA Submission
• Investigational Device Exemption (IDE)
• Emergency Use Authorization (EUA)
• Breakthrough Device Designation
• Review of marketing and advertising materials
• Review of publications and other materials for compliance
• Pre-submission meetings
• Technical File for CE Marking
• Design Dossier for CE Marking
• Health Canada MDL and MDEL
• Australian TGA approvals
• International Registrations

By leveraging our expertise and years of hands-on experience in solving intricate regulatory challenges, we design regulatory strategies that take your product to established and emerging markets worldwide in the most efficient manner. We provide strategies and execution in a very cost effective and timely manner.

Pre-clinical or Pre-market Service:

Prior to getting the product on market it is imperative to conduct pre-clinical  testing. At Kite Medtech we make sure all the Design inputs design outputs requirements are considered while designing the product, and then ensure the design verification validation activities are properly carries out. We can provide our expert services with:

• Predicate device selection
• Identifying Design inputs, outputs, design verification and validation testing requirements
• Defining applicable ISO and ASTM standards
• Suggesting the tests per the all the applicable standards
• Finding appropriate testing labs be it for animal testing or design verification testing
• Software development
• Point of contact for external parties involved in the submission
• Project Management
• Continuouos Risk Management

Services in Post-market:

Post market requirements are applicable once the product is launched and is on market. The manufacturer has to comply with various post market surveillance requirements such as complaints retrieval, analysis, periodic safety update report, post market clinical follow up etc. Kite Medtech has been consistently helping companies maintain such compliances by assisting with:

• Design Changes
• Process Changes
• Addition of new SKU’s
• Complaint Handling
• CAPA
• HHA