HaA PD Medical Device Regulatory Consulting Services
The path from concept to commercialization in medical devices involves more than just innovative engineering. Medical device regulation is a key factor influencing design, development, approval processes, and long-term market success. You need a deep understanding of this complex regulatory environment to bring safe and effective products to market.
At HaA PD, we provide our customers with comprehensive support and professional expertise. Our Medical Device Regulatory Consulting Services include the know-how and technical knowledge to design, test, and position your product in the medical device market, all while complying fully with regulatory requirements.
Why Regulatory Expertise Matters
The medical device regulatory environment is demanding and challenging.
The U.S. Food and Drug Administration (FDA) regulatory environment has never been more challenging. Manufacturers face unprecedented documentation demands and regulatory complexity.
It takes time, focus, and expertise to gather the necessary regulatory documentation and register with the relevant regulatory authorities. This mandatory phase is a highly complex, resource-intensive, and time-consuming task.
A single misstep in regulatory planning can cause delays, cost overruns, or market access denials. Our regulatory consulting services support your device development strategy to meet regulatory requirements from day one. HaA PD saves you time and resources, while maximizing your chances of market entry.
Our Comprehensive Regulatory Services for Medical Support
510(k) Premarket Notification
The 510(k) is for Class II devices that show substantial equivalence to existing legally marketed devices. Our team can examine your clinical and market research and run a comparative analysis to determine the appropriate predicate device to prove substantial equivalence. We can also help you design and validate testing protocols, submit the documents to the FDA, and work with them to review our application. With the proper preparation, medical devices may be cleared within as little as 90 days.
Premarket Approval (PMA)
PMA is the most demanding type of device marketing application required by the FDA for Class III devices. As part of our PMA services, we can help you design clinical trials and develop the relevant protocols. We can also compile effectiveness data and conduct risk-benefit analyses to support the medical device, as well as plan for post-market studies. HaA PD collaborates with the FDA, including meetings and interactions with their personnel, to ensure that your submission meets the scientific standards required for high-risk device approval.
De Novo Classification
The De Novo regulatory requirements are for medical devices of low to moderate risk that do not have a valid predicate device. Our consultants can help you develop classification requests, create new device category frameworks, and establish special controls for future predicates. This approach supports the development of innovative technologies that can be transformed into new device classifications.
FDA Pre-Submission Meetings
Pre-submission meetings are necessary because they provide a valuable opportunity to receive FDA feedback before submitting formal applications. We prepare for and participate in Q-Sub meetings, whereby we consult for risk determination and discuss protocol development.
We have a strong track record of working with the FDA and engaging in clear and effective communication throughout the regulatory process. With HaA PD, you receive clear guidance on regulatory expectations and submission requirements. This way, you have the best chances of first-cycle approval.
FDA Establishment Registration and Device Listing
All medical device manufacturers must register their establishments and list their devices with the FDA. We can help manage the medical device registration process, including initial establishment registration and device listing submissions. We can also assist foreign manufacturers with FDA agent designation and annual registration renewals. We have the expertise and systems in place to meet the FDA’s technical documentation requirements, including ongoing updates and renewals.
US Market-Focused Quality Assurance
FDA Design Controls Implementation
FDA's Quality System Regulation requires design controls for Class II and III devices.
Our design control systems include design planning and documentation, input and output specifications, review and verification protocols, as well as validation and transfer procedures.
We integrate our design and planning with FDA submission requirements, ensuring the final product complies with regulations from the outset.
US Regulatory Strategy Development
We can help you develop FDA-focused regulatory strategies that pave the way for the US market. Among other things, we offer device classification analysis and guidance on selecting the correct regulatory pathway. Our team plans for the FDA user fee and post-market regulatory compliance.
Our goal is to help you combine regulatory requirements with business objectives to minimize time and cost to market.
Advanced FDA Compliance Areas
Quality Management System Integration: ISO 13485 Implementation for FDA Compliance
FDA regulations require a strong Quality Management System.
We provide gap analysis and remediation planning to help you implement design controls and develop risk management processes for optimal performance and operational efficiency. We can also help you develop and maintain procedures for training, auditing, document control, etc., so that the final medical device is fully integrated with FDA regulations.
Our careful approach ensures that your Quality Management System (QMS) meets current FDA standards and adapts efficiently to changing regulatory requirements.
FDA-QMS Alignment
Our approach integrates FDA regulatory requirements directly into your Quality Management System (QMS). This way, any documentation that supports your medical device, from design to submission, will align with FDA requirements and regulations. HaA PD also oversees the control process and post-market surveillance.
Our integrated strategy streamlines processes to eliminate any redundant steps and strengthen overall FDA compliance.
Emerging Regulatory Challenges
QMSR Implementation
With the FDA Quality System Regulation (QSR) set to merge with ISO 13485 on February 2, 2026, HaA PD is already prepared for the upcoming regulation. Whether you are already ISO 13485 certified or not, HaA PD can help update your processes to be prepared for the major changes to terminology/definitions and implement a risk-based approach into your QMS.
Software as Medical Device (SaMD) for the US Market
Medical software is increasingly complex and demanding. The FDA has strict regulations in place that require expertise in classifying and categorizing the risk of SaMD — and our team understands its expectations for software-based medical technologies. These require algorithm validation and verification, as well as clinical evaluation for AI and machine learning devices. We can help you comply with FDA software guidance by monitoring post-market performance.
FDA Combination Products
Our team provides consultative services for combination products, including auto-injectors, pre-filled syringes, and patch delivery systems.
We can help you choose the correct FDA regulatory application format and consult with the Office of Combination Products to integrate your submission strategies. This will help you navigate the complex interplay between CDER, CBER, and CDRH requirements to ensure full compliance with the FDA.
FDA Post-Market Compliance and Surveillance
Medical Device Reporting (MDR)
FDA requires comprehensive adverse event reporting for medical devices.
We can help you establish MDR systems, including event identification and evaluation. These typically involve establishing reporting timelines and procedures, correction and removal processes, and annual summaries. We can also analyze trends and assess risk.
HaA PD further supports your medical device beyond design and development, by providing continuous marketing and offering ongoing support and expertise for continuing product improvement.
FDA Quality System Regulation (QSR) Compliance
Medical devices must maintain compliance with the FDA Quality System Regulation (QSR).
HaA PD focuses on manufacturing controls, supplier management, corrective and preventive actions, management responsibility, and design controls. We provide comprehensive QSR support, including gap assessments and other services. We can also help you develop procedures and training programs, and prepare your medical device for audit to make sure it consistently complies with 21 CFR Part 820.
Why Choose HaA PD for Regulatory Consulting
Proven Track Record
Our regulatory team has an unprecedented success rate for PMAs, 510(k)s, breakthrough designations, and CE mark applications. We bring decades of combined experience in medical device design, development, and marketing for Class I, II, and III medical devices.
Former Regulatory Authority Expertise
Our team includes staff with extensive knowledge of the FDA regulatory requirements. We have successfully helped companies develop hundreds of medical devices that have been approved by the FDA, transforming the performance and workflow of medical personnel.
End-to-End Device Consulting Services
HaA PD supplies medical device development services from device development to marketing, including regulatory support even beyond the marketing stage.
Our integrated consulting for medical services is designed to support your product throughout its entire lifecycle, as your success is our success.
Technology-Backed Efficiency
Unlike traditional consulting firms, our client services are supplemented with advanced in-house technology and driven by experienced subject matter experts. Thanks to our expertise and background, we consistently deliver high-quality project results quickly and cost-efficiently.
Getting Started with HaA PD
Everything begins with good planning.
During our initial consultation process, we will assess the device and evaluate the regulatory requirements needed. Together, we will develop a market strategy and a roadmap that aligns regulatory requirements with your business objectives.
HaA PD always works with a timeline that includes realistic milestones, because we want your medical device to reach the market as quickly, efficiently, and safely as possible. We also plan for contingency measures and allocate resources with efficiency and responsibility in mind.
We understand the risks and challenges associated with regulatory requirements. That’s why we continually monitor our FDA applications to identify and mitigate any potential regulatory risks early on.
Regulatory requirements can be daunting, but HaA PD has the know-how, professional background, and expertise to work alongside the FDA and meet its requirements and expectations.
When you work with HaA PD, you have experts who focus on reducing time to market for your medical device. HaA PD ensures that your medical device reaches patients safely and efficiently, and continues to make the world a better place.
Contact our regulatory team today to discuss your needs and discover how our medical device consulting services can help guide your product to the market success it deserves!