Medical Devices

SOMA Medical Device Solutions: Navigating Compliance and Innovation

In the rapidly evolving landscape of medical devices, adherence to regulatory standards is crucial for ensuring safety and efficacy. At SOMA Medical Device Solutions, we specialize in guiding companies through the complexities of medical device regulations, ensuring your products reach the market efficiently and compliantly.

According to the FDA, a medical device encompasses a wide range of products, from instruments and machines to in vitro reagents. These devices are classified into three categories based on risk:

• Class I: Low-risk devices with minimal regulatory controls.
• Class II: Moderate-risk devices that require specific performance standards.
• Class III: High-risk devices requiring extensive premarket approval.

Our team offers a full suite of regulatory services tailored to medical devices, including:

• Regulatory Strategy: We provide both short- and long-term regulatory strategies tailored to your specific device category, ensuring compliance with FDA regulations for medical devices, in vitro diagnostics (IVDs), and combination products.
• Submission Preparation: We assist in preparing regulatory submissions, including 510(k)s, PMAs, IDEs, and de novos, ensuring thorough documentation and adherence to FDA standards.
• FDA Interactions: Our experts represent clients during FDA meetings and Advisory Panel discussions, ensuring your interests are well-represented and understood.

Quality management is integral to the success of any medical device. Our services include:

• Quality System Documentation: We assist in developing comprehensive quality system documentation, including technical reviews of software development procedures.
• Training and Compliance: We offer in-house training on FDA regulatory issues and emerging policies to keep your team informed and compliant.
• Mock Audits: Our team performs mock audits to prepare you for actual FDA inspections, identifying potential compliance gaps and ensuring readiness.

At SOMA Medical Device Solutions, our mission is to support your innovation while navigating the regulatory landscape effectively. With our expertise, you can focus on developing groundbreaking medical devices that improve patient outcomes while ensuring compliance with all applicable regulations.

Contact us today to learn how we can assist you in bringing your medical device to market successfully and safely.