Medical Device Testing & Validation

MedLaunch Testing & Validation

1. Comprehensive Testing Solutions: Our suite of testing services includes, but is not limited to, biocompatibility testing, electrical safety testing, software validation, and mechanical testing. Our compliance with ISO 10993 and IEC 60601 promotes the safety and efficacy of your product.
2. Rigorous Validation Processes: We understand the importance of thorough validation in the medical device lifecycle. Our validation services cover process validation, software validation, and cleaning and sterilization validation, in compliance with FDA and EU MDR requirements. Our team aligns your processes and software with all necessary regulatory requirements, offering documentation and support for FDA 510(k) submissions and CE marking.
3. Quality Management Systems (QMS): QMS is crucial for achieving ongoing compliance and product quality. We assist in implementing and validating QMS tailored to medical devices, aligned with ISO 13485 standards, facilitating a streamlined approach to quality management and continuous improvement.
4. Custom Testing and Validation Strategies: Every medical device is unique, and so are its testing and validation needs. We collaborate closely with our clients to develop and execute custom testing plans that address specific product requirements, regulatory landscapes, and market goals.

Why Partner with MedLaunch for Testing & Validation?

• Extensive Expertise: Our specialists bring a wealth of experience to the table, informed by years of navigating the medical device regulatory environment and a deep understanding of industry standards.
• Global Compliance Assurance: We take pride in our up-to-date knowledge of global regulations and standards, guiding your products toward compliance and international market readiness.
• Collaborative Partnership: We view our clients as partners in innovation. Working closely with your team, we provide a seamless, transparent process from initial consultation to final validation.
• Innovation: Utilizing the latest in testing methodologies and technology, MedLaunch delivers efficient, accurate, and reliable testing and validation results, empowering you to lead in healthcare innovation.