FDA And ISO Regulations for Medical Devices in USA
Navigating Regulatory Complexities, accelerating Medical Innovation
Our goal is to ensure that your medical device not only meets regulatory standards but also achieves successful market entry and sustained compliance.
Services we Offer
We work With regulatory bodies throughout the world
- U.S. FDA (Food and Drug Administration) - 510(k), De Novo, IDE, PMA, etc.
- EU MDR & MDD - Technical Documentation, DoC, GSPR, ERC, etc.
- Health Canada
- Japan PMDA (Pharmaceuticals and Medical Devices Agency)
- China NMPA (National Medical Products Administration)
- Other Global Agencies (TGA, ANVISA, CDSCO, etc.)
Regulatory Strategy Development
Crafting a comprehensive regulatory strategy is the cornerstone of success in the medical device industry. Our experts work closely with you to develop a roadmap that ensures compliance while maximizing efficiency and minimizing time to market.
Regulatory Submissions
We are committed to guiding you through the regulatory submission process whether it be 510(k), De Novo, IDE, PMA, Q- Submissions, Pre-submissions, Technical Documentation, DoC, GSPR, ERC, Electronic Common Technical Document (eCTD), STEDs, etc. with expertise and dedication. Our comprehensive pre-market submission services ensure that your medical devices comply with global regulatory standards, facilitating a smoother, faster path to market entry. With extensive experience in regulatory affairs, we provide end-to-end support for your pre-market submission needs. Our dedicated team of experts works closely with regulatory agencies worldwide to ensure your submissions are precise, compliant, and timely.
Post-market Compliance
Compliance doesn't end with product launch. Our post-market support services ensure ongoing adherence to regulatory requirements, including adverse event reporting, post-market surveillance, corrective and preventive actions (CAPA), and recalls.
Labelling & Ad-Promo Documentation
Creating and reviewing product labels, manuals, marketing literature, and other documentations to ensure they meet regulatory requirements.
Support with Regulatory Compliance & Quality System Audits
Navigating the complex web of global regulatory and quality system requirements can be daunting. We provide support to our clients during FDA, Notified Bodies, or any other regulatory agency audits.
Quality Management Systems (QMS) Development & Implementation
A robust QMS is essential for maintaining compliance and driving continuous improvement. We provide comprehensive support in implementing QMS frameworks tailored to your organization's unique needs, ensuring adherence to ISO 13485, MDSAP, and other relevant standards.
Training & Education
Providing training on regulatory requirements, quality assurance process, and industry best practices.
Regulatory Intelligence
Monitoring and interpreting changes in regulations and guidelines that mat affect company's products and/or operations..
Contact Us Today
We understand the intricate web of regulations governing the medical device industry. We provide comprehensive regulatory and quality consulting services to ensure your product meets the highest standards of compliance while driving innovation forward.