Medical Device Regulatory Strategy
Integrated Strategy for Confident FDA Clearance
We combine and integrate regulatory planning into the development pipeline from day one. This way, you will never be caught off guard. Our expertise and experience in regulatory compliance help prevent costly delays, speed up paperwork, and let us handle FDA 510(k), EU MDR, and other international regulations with confidence.
Right from the start, our team will work with you to produce a full and comprehensive regulatory plan tailored to your device and target countries. We begin with a predicate device analysis to assess whether comparable cleared products exist, and what regulatory "gaps" will require additional testing or data collection. Then we research product requirements, setting deliverables like labeling, clinical evidence requirements, and Quality Management System (QMS) areas under ISO 13485 and FDA QSR 21 CFR 820.
As development moves forward, we will help your team with ongoing gap evaluations, such as prototypes and design verification, that match regulatory requirements. We help develop submission-ready documents: technical files, design history records, risk reports, and human factors/usability information. And when the submission date comes, we will handle the regulatory submission and planning. We also coordinate the specifications for engineering, which are required for FDA 510(k), EU MDR, CE marking, or approvals in other markets.
Our synchronized, proactive regulatory process meets design, engineering, usability, and quality testing, creating a much smoother, quicker, and reliable path for getting your product monetized. Our clients receive a clear plan and have a full grasp of the process, meaning that device development is lower risk and the device is designed for real-world use from concept to commercialization.
Why It Matters
Delays in regulatory feedback and approvals are the biggest causes of project delays.
Our experience and relationships can help you manage changing regulatory requirements and expedite the process, avoiding potential pitfalls along the way. This gives investors confidence to continue to fund your product’s development.
Our prioritized regulatory process makes the regulatory strategy a fundamental driver of product development. We regularly check and monitor updates to FDA guidance, EU MDR changes, and other local regulations. When you keep up with regulatory milestones throughout the development process, including design, verification testing, and clinical plans, you avoid any unexpected surprises nearing the end of the process.
When everybody is on the same page, the development process is smooth. Time-to-market is faster and is better positioned for effective regulatory review and faster commercial release.
Our Approach
Our team prioritizes regulatory strategy into the product development and planning stages from the start. We determine the product classifications and predicate the devices. We map all regulatory routes to approval as we advise for U.S. and international markets. Our approach means we work from idea and concept through to commercialization.
We collaborate with your quality, clinical, and engineering departments to build compliance into every step. We also check for and identify any potential roadblocks to regulatory approval early on. We conduct gap analyses and audit your documentation, design history files, technical files, and risk assessment reports to make sure that compliance with FDA and international standards remains intact.
Whether it is a 510(k), De Novo, or EU MDR pathway, we will develop a tailored regulatory compliance strategy specific to your device type, intended application, and target geography. You can then make the right decisions regarding testing needs, clinical data strategy, and human factors validation. Our strategy minimizes surprises, streamlines reviews, and sets you up for successful submissions into multiple geographies.
Our Regulatory Strategy Services Include:
Regulatory Planning, Roadmapping, and Strategy
Predicate Device Evaluation
Product Regulatory Requirements Research
Quality Management System (QMS) Development
US/EU/Global Regulatory Consulting
Gap Analysis of Existing Product Development Programs
Regulatory Submission Planning and Content Development
What You Get
With HaA PD, you get a comprehensive regulatory strategy, along with a complete and thorough risk assessment plan. Our team supplies submission-ready documents that pave your way to regulatory clearance.
We will also advise you on strategy at every stage. You will receive stage-one assistance in regulatory strategy, classification of your device, and validation of your intended use, along with integrated risk management in accordance with ISO 14971.
We will guide your team through all of the important design control procedures to help you determine clinical evaluation and labeling requirements, as well as usability engineering. As your product approaches the submission date, we will build and verify all components necessary for FDA 510(k), De Novo, or EU MDR submissions. We will provide you with technical files that are audit-ready and geared to the type of device you have.
Get in touch and explore our range of medical device development services to discover how our regulatory approach and strategy can help mitigate risks, inform strategic planning, and support submissions for faster approvals!