Medical Device Regulatory Compliance
Development based on Regulatory Requirements from Day One
When our team of experts develop a medical device we keep regulatory approval as our priority. Our goal is to deliver a device built in full alignment with regulatory standards right from the start. This avoids delays and costly re-work that would otherwise not occur with proper planning. From FDA QSR, to ISO 13485 and EU MDR, we put regulatory compliance at the heart of the development process. This means we avoid regulatory mishaps during later development stages.
We design Class I, II, and III devices, and we take into account 510(k), De Novo, and PMA submissions from the concept validation stages all the way through to approval and beyond. Our deliverables include predicate device analysis, pre‑submission meeting preparation, and post‑market surveillance programs, including CAPA processes.
Why It Matters
Regulatory compliance throughout the development process reduces the risk of delays and unnecessary, costly re-work due to not taking regulatory requirements into consideration early. When development is done right there is less potential for a submission to be rejected. Compliance with regulatory guidelines throughout the development process mitigates delays and maximizes efficiency.
Costly mistakes
The medical device regulatory approval process can be challenging and stressful. Regulatory bodies around the world, such as the FDA, European Medicines Agency, Health Canada, and other foreign authorities, have strict controls to protect patient safety. A single regulatory compliance mistake can trigger extensive corrective actions and require costly redesign. Even worse, it can result in market removal that can wipe out decades of work and investment.
Confidence in the device and the business itself
Companies face significant financial losses when they delay market access. In addition, when a medical device doesn’t fulfill compliance regulations, it hurts stakeholder confidence and negatively influences investor relations for all funding opportunities.
National and international markets are connected
The international nature of markets means that non-compliance in one jurisdiction can put it under the spotlight elsewhere, compounding effects and doubling your risk. Active compliance isn't just about avoiding problems; it's about building a long-term competitive advantage by having operational excellence and regulatory compliance.
It is more efficient and safer for users and patients to introduce regulatory compliance from the first development stages.
Our Approach
Regulatory-ready documentation
Our team of experienced regulatory leaders is abreast of all current requirements. We produce traceable, audit-ready documentation throughout the entire life cycle of your device. We create a proactive compliance framework that follows the current regulatory requirements. Our methodology integrates seamlessly into your development workflows, without disrupting the controls and documentation that auditors request.
Regulatory compliance from the beginning
With each new project, we share valuable insights with our clients through a comprehensive regulations review and an in-depth regulatory strategy. We map your device classification, intended use, and target market to determine the specific regulatory requirements you will need to meet. Our team ensures your compliance plan has an established platform to give it global access to markets from the outset of the project. We can also train your team to develop regulatory thinking in day-to-day decision-making so that you can utilize this knowledge during our work together and well beyond. This is a good development practice that pays off in the end and reduces unexpected burdens throughout the medical device development process.
Compliance program tailored to your device
Every compliance program we design is based on your device's specific risk profile, regulatory approach, and commercial schedule. We establish clear steps that match regulatory deliverables with development phases. Our goal is to make regulatory compliance efficient.
Our regulatory experience means your device is developed on a solid foundation and that you have traceable, auditable documentation throughout its lifecycle.
Our Regulatory Compliance Services Include:
Guidance on Medical Device Standards.
Expert interpretation of applicable rules and harmonized standards specific to your device type.
FDA Quality System Regulation (QSR) - 21 CFR Part 820 - Complete implementation support for FDA quality system regulations.
ISO 13485:2016 Quality Management System Implementation - Systematic deployment of international quality management standards.
Compliance Audits and Gap Assessments - Thorough evaluation of current compliance position with action plans for remediation.
Integration of Regulatory Controls into Development Process - Intuitive merging of compliance regulations into processes.
Post-Market Surveillance - Ongoing surveillance and reporting systems that maintain regulatory status throughout the product life cycle.
Our services go much further than the initial device regulation compliance to include consistent regulatory monitoring, submission strategy development, and regulatory agent engagement. We provide training programs to develop in-house regulatory expertise, and we establish sustainable compliance management systems.
What You Get
We supply your organization with a streamlined, regulatory-compliant product development process that meets worldwide regulatory standards with the supporting documentation for submission.
You will receive all required regulatory documentation. Our approach is efficient because it reduces the overall cost of development, reduces unnecessary errors and shortens regulatory approval timelines.
Clean, compliant documents make it easier and faster to submit for regulatory approval. Using this proven process, we keep review cycles to a minimum and gain regulatory approvals the first time we submit.
Our deliverables include comprehensive compliance guides, qualified procedures, training programs, and audit-ready packages of documentation that cover all regulatory requirements. You have real-time access to compliance status, regulatory risk exposure, and remediation priority at every milestone of development.
Most importantly, your medical device meets regulatory compliance that supports long-term commercial success and assures patient safety. Our team of experts and their experience adds value to your investment and maximizes the potential to bring life-saving medical innovations to market.
Contact HaA Product Development today and let us help you bring your vision to life!