Your trusted medical device testing laboratory for US compliance
Comprehensive testing solutions to get your devices to market faster and meet the global regulatory standards
We provide standardized and customizable testing packages specifically designed to support medical device manufacturers in complying with regulatory submission requirements such as FDA submission and MDR submission.
Our laboratory in Germany combines over 30 years of expertise in medical device testing with ISO/IEC 17025 accreditation and GLP certification for a broad range of methods.
Why Medical Device Safety is Non-Negotiable
“Validation activities are critical to ensuring that a medical device is designed and produced to consistently meet user needs and intended uses..”
✓ Patient safety depends on accurate, reliable validation data, ensuring that devices are free from contaminants such as bioburden, endotoxins, and particles.
✓ Regulations (FDA, EU MDR) enforce strict standards
✓ Preventing failures saves costs
✓ Any compromise risks lives, trust, and the future of medical tech.
What is an FDA Medical Device Submission?
An FDA Medical Device Submission is the regulatory process required to bring a medical device to the U.S. market. Depending on the risk classification of the medical device, the submission could be a 510(k), De Novo, or Premarket Approval (PMA). Each pathway requires detailed technical documentation, clinical or performance data (if applicable), and evidence of compliance with FDA regulations. The goal is to ensure that the device is safe, effective, and meets the required quality and performance standards for its intended use as defined by the manufacturer.
Why Choose GBA Group as your Medical Device Testing Laboratory?
We provide end-to-end support across the entire medical device lifecycle. As part of the Medical Device Sector within the GBA Group, one of Europe’s leading providers for the qualification and biological evaluation of medical devices, and an international service provider in the life science industry with over 60 sites in 14 countries, we offer professional regulatory expertise and global perspective. Our team provides comprehensive support in testing medical devices to meet stringent regulatory and safety standards. We guide you through essential evaluations such as clinical performance testing, biological safety assessments, and verification of compliance with ISO 13485 and FDA requirements. By integrating testing into the broader regulatory pathway, whether 510(k), PMA, or De Novo, we ensure your product meets both US and EU standards. From test planning and documentation to final validation, we combine technical expertise with regulatory insight to accelerate your device’s approval and market readiness.
Our Customer Include
Small to mid-sized medtech companies
Large device manufacturers seeking cost-effective alternatives
Companies preparing for FDA/MDR submissions
Startups needing fast, compliant, and affordable testing
Key Advantages for US Manufacturers
All required FDA/MDR tests in one hand
Globally recognized quality: ISO/IEC 17025 accredited and GLP certified
Competitive pricing compared to US labs
Fast and reliable turnaround times
- End-to-end logistics to minimize administrative burden
Our services
Our Medical Device Testing Laboratory provides high-quality services covering Cleanliness Validation, Reprocessing Validation, Biocompatibility Test, Medical Device Monitoring.
Discover Our Testing Packages Here
Simple Sample Logistics for US Clients
Hassle-Free International Shipping:
Ship your samples to our US-based affiliate
We manage global logistics, customs, and documentation
Fast processing time and digital delivery of results
Effortless for You. Compliance Handled by Us.
FAQ – Frequent Asked Questions
Q: What is an FDA medical device submission?
A: An FDA medical device submission is the regulatory process to bring a medical device to the U.S. market. Depending on risk class, it may be a 510(k), De Novo, or PMA submission, each requiring technical documentation, performance data, and proof of compliance with FDA safety and quality standards.
Q: What are cleanliness validation and reprocessing for medical devices?
A: Cleanliness validation is to ensure a proper cleanliness during the manufacturing process that is essential to deliver medical devices that are safe for patients, users, and third parties. Cleanliness is essential for successful sterilization, reprocessing, and ensuring biocompatibility. Reprocessing of reusable medical devices is essential to ensure that the instruments are free from contamination before each use, eliminating any risk of infection for patients.
Q: What is a medical device biocompatibility test?
A: A medical device biocompatibility test assesses the biological safety of a device as part of a risk management process under ISO 14971 and ISO 10993-1. It identifies potential biological hazards, evaluates associated risks, and ensures the device remains safe both at first use and throughout its life cycle.
Q: How does GBA Group support FDA and EU MDR submissions?
A: We at GBA MDS provide ISO/IEC 17025 accredited testing for both FDA and EU MDR requirements, covering cleanliness, reprocessing, biocompatibility, and other essential evaluations. We also deliver the necessary documentation to support 510(k), De Novo, PMA, and MDR submissions.