Pathway Medtech`s design team and quality assurance experts use their extensive knowledge to guide a product through the entire development life cycle, offering a strategic and customized approach to bring a medical device to market.
As you design your viable medical device, the time comes to identify its intended use and move to the regulatory strategy phase. It is true — regulatory strategy can make or break the journey to FDA approval. This is why it is important to work closely with a team familiar with every potential hurdle. Please note that the Center for Devices and Radiological Health (CDRH) is the branch of the FDA that oversees the regulatory and quality assurance processes for the approval of medical devices.
Most medical device developers hire a consultant to review a proposed product, evaluate existing products in the FDA market, and deliver a summary report on a potential testing roadmap and market introduction strategy. Our approach is far more unified. Pathway Medtech integrates design, regulatory strategy, and manufacturing processes to optimize the entire team’s efforts and deliver quick, effective solutions to overcome any challenges along the way. We are in the trenches with you, developing your crucial medical device technology for ultimate market success. This approach often shortens the overall FDA approval runway for our clients.
While the exact timeline and regulatory requirements are product-dependent, we are confident in our unique and agile product development approach, thanks in large part to our fully integrated quality control system.
A Product Development Approach with Integrity
Building and maintaining a robust quality system can be time-consuming and expensive. Fortunately, Pathway Medtech’s in-depth quality control process allows for smart evaluation of the FDA roadmap with the understanding that every hour counts. We offer customized approaches to quality system management – another key differentiator in our industry – that are tailored to meet your needs as you grow. This strategy, supported by our team’s diverse skill sdset, enables a holistic medical device development journey underscored by integrity.
Cloud-Based Quality Assurance System
Pathway Medtech can assist with your product quality/registration requirements by:
- maintaining FDA registration on your team’s behalf and conducting quality management activities within our FDA and ISO 13485-registered system
- providing a cost-effective, highly capable virtual team to keep the process going
- building a cloud-based quality assurance system that takes you from your first quality manual to product introduction, as well as ongoing systems management
Our expert team will work with your organization to identify the right fit for you.
Regulatory
Get great value by crafting an FDA regulatory strategy and execution plan with the help of Pathway Medtech. The right regulatory approach is equally as important as developing a quality product. We have extensive experience in navigating the regulatory landscape and a proven track record of successful, streamlined execution.
Pathway Medtech places a premium on the quality assurance process, ensuring that your product is ready for market based on the FDA’s specifications. While being ISO 13485 compliant is independent of FDA mandates, its designation provides an extra layer of confidence that medical devices produced in our facilities are consistent with industry experts’ standards. Pathway Medtech’s regulatory team is well-versed in assessing risk management, assuring that clean houses are suitable for medical device production, and quality assurance measures are consistent and uniform throughout each product cycle.
Verification and Validation
Preparation for FDA submission and registration includes the creation of a technology’s design history file in collaboration with our innovators. All verification and validation activities are conducted with professionalism and speed thanks to Pathway Medtech’s extensive product development experience.
Our verification and validation expertise includes:
- Determining if your medical falls under Class I, II, or III
- Investigational device exemption (IDE)
- Premarket (e.g., 510(k)) generation, review, and submission
- Premarket approval (PMA) application
- De novo (alternative to PMA) classification
- Humanitarian Device Exemption (HDE)
- Product/packaging validation
Ready to get started, or just need help understanding your regulatory responsibilities? Contact us for initial consultation on your quality control and assurance needs or for a free custom analysis.
Get Started
Ready to get started? Contact us for an initial consultation on your new design or free custom analysis.
Contact us for a consultation.