We are driven by a mission to assist manufacturers in the efficient deployment of innovative medical software products. Through our comprehensive management of regulatory compliance, we ensure that impactful software solutions secure their position in the market and continue to make a difference in the lives of everyday people, regardless of the dynamic regulatory landscape. With our practical approach, we simplify the process of achieving regulatory compliance, freeing you to prioritize the delivery of exceptional medical software.
We offer end-to-end leadership and guidance for EU MDR and FDA regulatory and quality compliance for medical software. Our services cover the entire process, from device classification to compiling regulatory submissions, providing comprehensive solutions to ensure your success.
We conduct analysis to identify gaps in complying with applicable regulations, guidances, and international standards. Our comprehensive approach to compliance analysis ensures you are implementing the correct standards for your business and products. With our help, you will meet all the necessary requirements and stay ahead of the curve.
We will help you navigate the complex landscape of regulatory compliance and implement a Quality Management System (QMS) that meets all the necessary requirements for your specific market and device type. With our help, you will be able to implement a QMS that is lightweight and optimized for designing and developing medical software.
We will guide you through the entire regulatory submission process, develop your regulatory strategy, compile your 510(k) and/or technical documentation and help you submit your application for approval. During the approval process, we will support your communications and answer all questions from notified body and FDA.
February 4, 2024
Presenting a detailed step-by-step approach to assist medical software manufacturers in successfully implementing EU MDR requirements.
February 4, 2024
We'll guide you through the process of developing an effective software validation plan tailored for medical device software. Whether you're a seasoned professional or new to the field, this guide will equip you with the knowledge to navigate the complexities of validation with confidence.
February 4, 2024
Diving into a crucial aspect of the medical device world: risk management for software as medical devices (SaMDs).
We specialize in medical software and understand the complexities andnuances of the medical software industry, and our team has the specialized knowledge and experience to help you navigate regulatory requirements andoptimize your product development process.
We will help you understand the unique challenges associated withdeveloping AI-powered medical software and ensure that your product meets allregulatory requirements.
Our team has extensive experience working with both the FDA and EUregulatory bodies and will help you understand the requirements, prepare thenecessary documentation, and ensure compliance so you can get your product tomarket as quickly and efficiently as possible.
We understand that meeting regulatory requirements is just one aspect ofyour business. That's why we take a holistic and risk-based approach thatbalances regulatory compliance with quality assurance and meeting your businessneeds. We'll work with you to find the optimal solution that meets all of yourgoals, whether that's getting your product to market quickly, maximizingquality, or optimizing for cost-effectiveness.
We believe in taking a hands-on approach to helping our clients achieveregulatory compliance. We'll work with you every step of the way, driving theprocess of establishing regulatory compliance from start to finish. Our teamwill help you ensure that your product meets all regulatory requirements, soyou can bring it to market with confidence.
We pride ourselves on our approachable and collaborative working style.Our team is always willing to listen to your concerns, answer your questions,and work with you to find the best solutions for your unique needs. We're alsoflexible and able to adapt to your changing needs as your project evolves.
ISO 13485 - Quality Management System
ISO 14971 - Risk Management.
IEC 62304 - Software Development Lifecycle
AAMI TIR45 - Agile Software Development
IEC 82304 - General requirements for product safety
IEC 62366 - Usability Engineering
ISO 15223 - Symbols
ISO 20417 - Information supplied by manufacturer
We handle the regulatory and quality compliance of your medical software, so you can focus on innovation and growing your business.
Analyzing the business and the product
Identifying the regulatory requirements for target markets
Conducting the gap analysis
Creating regulatory strategy
Gathering required information
Revising QMS
Assembling product documentation
Creating regulatory strategy
Submitting documentation for regulatory approval
Directing relationship with regulatory bodies
Supporting audits
Addressing questions from regulatory bodies
