RQM+ focuses on offering comprehensive analytical laboratory services and material science solutions specifically designed to cater to the requirements of medical devices, pharmaceuticals, consumer products, and polymers. When speed and quality are of utmost importance, it is essential to have a partner who can provide reliable results.
Jordi Labs, an RQM+ company, is acknowledged by the FDA as the benchmark for chemical characterization and extractables and leachables (E&L) testing, offering vital insights that guarantee product safety and adherence to regulatory standards.
With over 40 years of experience, RQM+ simplifies complexity into clarity – providing quicker timelines than the industry average and pricing that positions users for success.
The core lab services
Chemical characterization
Analysis of extractables and leachables (E&L), polymer deformulation, identification of unknown substances, and investigations into contaminants.
Biological evaluation
Evaluations of biocompatibility and toxicological risk assessments are conducted to comply with ISO 10993 standards.
Investigative testing
Detect unforeseen contaminants, degradation pathways, or unidentified compounds. Address intricate chemical and materials challenges.
Toxicology
Professional toxicological evaluations for biocompatibility, extractables and leachables (E&L), and impurity analysis. Supporting risk assessments and regulatory submissions across various product categories.
Regulatory submission support
Comprehensive documentation to facilitate approval procedures with the FDA and notified bodies.
Failure analysis
Thorough investigations aimed at uncovering root causes and delivering actionable insights.
Extractables and leachables
Guarantee patient safety and adhere to global regulations through focused E&L studies. Accurate identification of the product and material category.
Key benefits
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Partnering with RQM+ delivers:
Regulatory confidence
Methods recognized by the FDA, comply with the highest global standards.
Comprehensive testing solutions
60+ analytical techniques to solve the most complex challenges.
Faster approvals
Precise data to support efficient regulatory submissions.
Leading-edge testing facilities
Cutting-edge technology and equipment.
Explore Jordi Labs analytical expertise
Medical devices
Comprehensive testing customized for device compliance.
Pharmaceuticals
Thorough solutions designed to comply with stringent regulatory requirements.
Chemical and cosmetic products
Creative strategies to guarantee the safety and quality of products.
Jordi Labs’ demonstrated expertise
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- Trusted by prominent medical device and pharmaceutical firms globally
- FDA-recognized extractables and leachables methods are often referenced in regulatory guidance documents
- Comprehensive knowledge in ISO 10993 biocompatibility testing
Flexible partnering solutions
Outsourcing
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This service offers customizable and scalable solutions tailored for complete projects, specific functions, or defined segments of a function. Users can utilize RQM+'s expertise and adaptability, enabling their teams to concentrate on essential skills, company objectives, and advancements.
Consulting
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This service offers focused expertise with specific outcomes to address particular MedTech challenges. RQM+ consultants offer useful, implementable advice and direct execution to facilitate prompt solutions.
Staff augmentation
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This service addresses skill or capacity deficiencies with MedTech professionals from RQM+. It delivers professionals on demand, functional service assistance, rapid implementation for strict deadlines, and contract-to-hire choices that integrate smoothly with the user's team.
Ready to make MedTech happen?
RQM+ transforms testing obstacles into regulatory achievements. Bring new items to market faster.