Medical Device Quality Assurance
Quality delivers Safe, Compliant, and Dependable Devices
When it comes to product development, we take quality seriously. Our quality assurance team ensures your device meets global quality standards and is built for safe, dependable, real-world performance.
We are ISO 13485 and FDA QSR-compliant and have a rigorous process in place to support critical aspects of the quality management system such as design history files, document control, training procedures, internal and supplier audits, and post-market surveillance planning. Quality systems drive our support for our clients, and we ensure our clients understand the most effective ways to navigate the complex regulatory submission process.
Quality assurance is embedded into every aspect of the product development process. This ensures that the product developed will be safe and reliable. HaA PD delivers the quality assurance you need so that your product works reliably every time.
Why It Matters
The medical device industry is highly regulated. You have to prove that your device is safe, reliable, and compliant to get approval. Our quality assurance protocols allow us to identify any concerns early on so that we can address them. You can ensure that by working with us, we will deliver a safe and effective medical device so that you can confidently begin your commercialization journey.
Medical device development requires precision in every step of the process. Mistakes can lead to patient harm, regulatory rejection, costly recalls, and litigation that can harm or sometimes destroy a business. Device companies have a heavy responsibility when it comes to protecting end users. In addition, any issues can result in your device being perceived as poor quality which can damage your reputation irreparably. Regulatory bodies like the FDA,EU notified bodies, and other international authorities review each aspect of your device to reduce any risk of these catastrophic failures. To ensure quality, we:
Apply quality assurance standards to uphold the reliability and safety of your medical device. This is critical because even minor shortcomings can lead to costly rework and approval delays.
Ensure you submit complete risk documentation so that you move swiftly through regulatory submissions and avoid delays and resubmissions.
Ensure traceability so that when auditors request evidence of your design controls you are ready to share the necessary paperwork.
These are just a few examples of how quality assurance protocols ensure you are ready to obtain approval with a safe, effective and reliable medical device.
Our Approach
At HaA PD, we focus on quality and risk management at every stage of our product development process.
We use a proactive quality management system that anticipates regulatory expectations rather than reacting to them. Our process is built on years of experience, and we know the documents and quality assurance steps that regulators require. Our knowledge and expertise ensure you have a smooth pathway to regulatory success.
Systematic approach
Quality assurance is not just about checking boxes. Our team knows that it's about developing systematic processes that yield consistent, predictable outcomes. We work with you to instill quality thinking into all working practices related to the performance of your device. The goal is to make quality assurance second nature, so that structure is automatically factored into every step of the process from the start.
Customized quality plan
Each product is accompanied by a customized quality plan tailored to your device's specific regulatory requirements, risk profile, and commercial strategy. Our team of experienced leaders stay current with all FDA and EU MDR requirements, as well as other critical medical device standards so that you know exactly what you need to prove right from the start.
Our Quality Assurance Services Include:
Risk Management Plan Development - Detailed outline of how we will identify, analyze, and manage potential risks throughout the development and life cycle of the device.
Risk Analysis and Risk Management Reports - Comprehensive reports that summarize systematic hazard analyses and control measures.
Defining and Validating User Needs - Accurate definition of user needs with objective evidence of need satisfaction.
Design Input and Output Definition - Precise information that defines product requirements and their corresponding, measurable product specifications.
Design Verification and Validation Planning - Pre-arranged test protocols that verify your device is safe and effective.
Complete Requirement Traceability Matrix - Traceability from user needs to design inputs, outputs, verification, and validation activities.
Help with Design History File (DHF) Compilation - Organized package documentation to submit in compliance with regulations.
The services we offer include documentation as well as training your staff on best practices in quality control and implementing sustainable quality management systems. We support your team throughout the entire product management process.
What You Get
We will continuously assess your device throughout the design process to protect you from expensive mistakes and setbacks down the line. Our goal is to help you gain FDA or EU MDR approval so that you can bring your device to market to commercialize..
Our quality assurance process sets the stage for efficient manufacturing because it streamlines regulatory submissions and reduces post-marketing surveillance burdens. Ensuring you have all required documentation accelerates approvals, while thoughtful risk management protects you from costly late-stage design changes. Therefore, our quality assurance process will give your company a competitive advantage.
Our quality assurance process provides quality manuals, certified procedures, training documents, and audit-ready document packages. You’ll clearly understand your project’s status and how your device is positioned for regulatory approval and risk mitigation every step of the way.
With HaA Product Development, you will have confidence that your device will safely and effectively perform at commercialization. Our quality assurance processes will not only protect all key stakeholders - you, the clinicians who will use your product, the patients - but also the investment you have made into your device. Contact us today and let us bring your vision to life!