Laboratory Equipment Certification:
Your Path to 61010 Compliance Specialized Expertise: Laboratory Analyzers & Diagnostic Equipment
For over 35 years, Product Safety Consulting has been the trusted partner in laboratory equipment certification, specializing in analyzers and diagnostic equipment testing. We understand that when your equipment gets red-tagged, you need swift, reliable solutions to get back to business. Our expertise in FDA 510K recognized standards and 61010 certification ensures your path to compliance is smooth and efficient.
From Complex Requirements to Clear Solutions
The world of laboratory equipment certification can feel like navigating a maze of technical requirements and regulatory standards. That’s where our experience makes all the difference. Since 1988, we’ve guided countless manufacturers and laboratories through the certification process, transforming complex requirements into clear, actionable steps.
Our experts specialize in testing and certifying:
- Analytical instruments and chemical analyzers
- Clinical diagnostic equipment
- Laboratory centrifuges and separation devices
- Precision measurement instruments
- Temperature control and environmental chambers
- Spectrophotometers and optical equipment
Laboratory Analyzers & Diagnostic Equipment: Specialized Expertise
In the rapidly evolving world of laboratory analysis and diagnostics, equipment certification demands a unique blend of technical knowledge and regulatory understanding. Our specialized focus on laboratory analyzers and diagnostic equipment sets us apart in the certification industry. We understand that these sophisticated instruments, from clinical chemistry analyzers to advanced diagnostic platforms, require precise evaluation of both safety and performance parameters.
Control Laboratory Equipment & Pump Certification:
Advancing Safety Standards Through 61010 Compliance
Laboratory Equipment Certification:
Your Path to 61010 Compliance Specialized Expertise: Laboratory Analyzers & Diagnostic Equipment
Laboratory Stirring & Shaking Equipment Certification:
Meeting Critical Safety Standards
Key Areas of Laboratory Equipment Expertise:
Advanced Analytical Systems
We work extensively with manufacturers of high-precision analytical instruments, including mass spectrometers, chromatography systems, and spectrophotometers. Our certification process accounts for the unique challenges these systems present, from complex electronic interfaces to precise calibration requirements.
Clinical Diagnostic Platforms
For diagnostic equipment manufacturers, we provide comprehensive certification services that align with both safety standards and clinical accuracy requirements. Our experience covers automated immunoassay analyzers, molecular diagnostic systems, and point-of-care testing devices.
Laboratory Automation Solutions
As laboratories increasingly adopt automated systems, we’ve developed specific expertise in certifying robotic sample handling systems, automated pipetting stations, and integrated laboratory automation platforms. Our certification process addresses both the mechanical safety aspects and the sophisticated control systems these devices employ.
Custom Test Protocols
We recognize that many laboratory analyzers and diagnostic systems incorporate proprietary technologies or unique operational features. Our team develops custom test protocols that thoroughly evaluate these specific aspects while ensuring compliance with all relevant standards.
The PSC Advantage: Design First, Test Once
Our signature DFSA™ (Designing for Safety Approvals) approach has revolutionized how laboratory equipment manufacturers approach certification. By integrating safety considerations from the earliest stages of design, we help you avoid costly redesigns and ensure your equipment passes certification the first time.
Comprehensive Support at Every Stage
From initial concept to final certification, we provide end-to-end support including:
Early Design Consultation
We review your designs before production, identifying potential compliance issues when modifications are least expensive. Our team works alongside your engineers to integrate safety requirements seamlessly into your product design.
Technical Documentation & Risk Assessment
Our comprehensive documentation services ensure every aspect of your equipment’s safety features is properly recorded and verified. We conduct thorough hazard analyses and risk assessments, creating detailed reports that stand up to regulatory scrutiny.
On-Site and Laboratory Testing
With state-of-the-art testing facilities and mobile capabilities, we offer flexible testing solutions that fit your needs. Whether testing at our facility or yours, we ensure thorough evaluation against all applicable standards.
Streamlined Certification Process
Our established relationship with certification bodies and intimate knowledge of their requirements means we can navigate the submission process efficiently. We manage all aspects of submittal, from documentation preparation to final approval.
Real Expertise, Real Results
Our team includes industry veterans who understand both the technical and practical aspects of laboratory equipment certification. We’ve helped manufacturers and laboratories across the globe achieve compliance while minimizing downtime and controlling costs.
Looking Ahead: Future-Proof Compliance
The regulatory landscape for laboratory equipment is constantly evolving. Our ongoing involvement with standards committees and industry organizations means we’re always ahead of the curve, helping you prepare for upcoming changes before they impact your operations.
Ready to Begin?
Whether you’re facing a red-tag situation, developing new equipment, or planning for future certification needs, we’re here to help. Contact our team to discuss your specific requirements and learn how we can make your certification process smooth and successful.
Remember: Early involvement leads to better outcomes. The sooner we’re involved in your project, the more we can help you avoid potential issues and ensure a straightforward path to certification.
Ready to
Get Started?
Contact us today and let us embark on the journey to product safety and compliance together.