Cormica
Cormica® Ltd
Cormica offers comprehensive biocompatibility testing services for medical devices, ensuring safety and compliance with ISO 10993 standards. Accelerate your product development with expert guidance and reliable data.
Cormica provides expert biocompatibility testing services for medical devices and combination products, ensuring they meet stringent ISO 10993 standards and global regulatory requirements. With decades of experience and GMP, GLP, and ISO 17025 accredited laboratories across the UK, EU, and US, Cormica supports manufacturers from R&D through to post-market surveillance. Their services include developing Biological Evaluation Plans (BEPs) and Reports (BERs), and navigating complex regulations like EU MDR and FDA guidance. Cormica's team offers clear guidance, dependable timelines, and data you can rely on, helping you move products forward with confidence. They specialize in assessing interactions with biological systems to ensure product safety for human use, offering a comprehensive suite of tests tailored to your device's intended use and contact duration. Leveraging a scientist-to-scientist approach, Cormica ensures reliable and reproducible results, accelerating your path to market. They are committed to improving patient lives by enabling safe and timely product launches through comprehensive and reliable testing solutions.
About
**Who they are**
Cormica provides comprehensive biocompatibility testing services for medical devices, ensuring safety and compliance with ISO 10993 standards. They offer expert guidance and reliable data to accelerate product development.
**Expertise & scope**
* Comprehensive ISO 10993 testing services for medical devices and combination products.
* Evaluation of how medical devices interact with biological systems to ensure safety for human use.
* Testing programs cover the entire product lifecycle, from early development to commercial production and lifecycle management.
* Expertise in various medical device categories including pre-filled syringes, auto-injectors, inhalers and OINDPs, intraocular lenses, and anesthesia & respiratory devices.
* Services include analytical chemistry, microbiology & sterility, physical & packaging testing, biocompatibility & toxicology, and consultancy & scientific support.
* Support for international standards such as ISO 10993 series, ISO 11040, ISO 11608, USP <1207>, ISO 11607, ISO 20072, ISO 27427, ISO 18562, and ISO 11979.
**Reputation / proof points**
* Decades of scientific expertise and experience supporting hundreds of device programs worldwide.
* Global facilities and experienced scientists.
Cormica provides comprehensive biocompatibility testing services for medical devices, ensuring safety and compliance with ISO 10993 standards. They offer expert guidance and reliable data to accelerate product development.
**Expertise & scope**
* Comprehensive ISO 10993 testing services for medical devices and combination products.
* Evaluation of how medical devices interact with biological systems to ensure safety for human use.
* Testing programs cover the entire product lifecycle, from early development to commercial production and lifecycle management.
* Expertise in various medical device categories including pre-filled syringes, auto-injectors, inhalers and OINDPs, intraocular lenses, and anesthesia & respiratory devices.
* Services include analytical chemistry, microbiology & sterility, physical & packaging testing, biocompatibility & toxicology, and consultancy & scientific support.
* Support for international standards such as ISO 10993 series, ISO 11040, ISO 11608, USP <1207>, ISO 11607, ISO 20072, ISO 27427, ISO 18562, and ISO 11979.
**Reputation / proof points**
* Decades of scientific expertise and experience supporting hundreds of device programs worldwide.
* Global facilities and experienced scientists.
Additional information
Cormica's approach to medical device testing emphasizes a full lifecycle support model, ensuring that safety and compliance are addressed from initial design through to post-market surveillance. They work with clients to determine the appropriate ISO 10993 tests based on the product's intended use and contact duration with the body, utilizing a matrix approach to guide test selection. Their services are designed to generate regulator-ready data, facilitating smoother submissions and market access. Clients can expect coordinated testing programs delivered by experienced scientific teams, aiming to identify potential risks early in the development process.
Key Highlights
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Offers comprehensive ISO 10993 testing services for medical devices.
Source
“Cormica provides comprehensive ISO 10993 testing services, offering expert guidance to help you navigate the complex requirements of medical device testing.”
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Supports a wide range of medical device types including pre-filled syringes, auto-injectors, and intraocular lenses.
Source
“Pre-Filled Syringe Testing; Auto-Injector Testing; Inhaler & OINDP Testing; Intraocular Lens Testing”
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Expertise covers analytical chemistry, microbiology, physical testing, and biocompatibility.
Source
“Our global team of experienced scientists works across microbiology, analytical chemistry, physical and functional testing, and biocompatibility to deliver coordinated testing programmes.”
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Aligns testing programs with key international standards including ISO 10993 series and ISO 18562.
Source
“Supporting you with ISO 10993-1 2025, EN ISO 10993-1 2020, FDA guidance September 2023 and ISO 18562-1”
Certifications & Trust Signals
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Decades of scientific expertise in medical device testing.
Source
“Our global team of experienced scientists works across microbiology, analytical chemistry, physical and functional testing, and biocompatibility to deliver coordinated testing programmes.”
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Experience supporting hundreds of device programs worldwide.
Source
“Decades of experience supporting hundreds of device programmes worldwide help teams move from R&D to commercialisation with confidence and regulator-ready data.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance testing.
- Companies developing combination products requiring rigorous safety evaluations.
- Firms needing support across the entire medical device lifecycle.
How engagement typically works
- Collaborative, expert-led guidance.
- Data-driven approach to regulatory submissions.
- End-to-end testing program management.
Typical deliverables
- Biocompatibility test reports.
- Toxicological risk assessments.
- Analytical chemistry data.
- Microbiology and sterility reports.
- Physical and packaging test results.
Good to know
- Best when requiring specialized biocompatibility and medical device testing expertise.
- Ideal for products with complex biological interactions or long-term patient contact.
HQ:
London, UK
Languages:
English
Timezones:
UTC, GMT, BST
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Japan, South Korea, Asia
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Biodegradation, Other
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
No
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Regions Served:
UK, EU, US
Lead Time Band:
Start in 0-2 weeks
Quote SLA:
24-48 hours
Accreditation Body:
ISO 17025
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, EN ISO 10993-1, ISO 18562
Test Types Offered
Biocompatibility testing, Genotoxicity, Local Effects After Tissue Contact, Chemical characterisation, Extractables and leachables, Impurities, Materials analysis, Bioburden, Sterility, Pyrogen, Environmental monitoring, Device performance, Mechanical integrity, Packaging validation, Distribution testing, Biological evaluation, Toxicological risk assessment, Particulate risk, Volatile organic compounds (VOCs).
Contact Types Supported
Surface contact, External communicating, Implant, Extracorporeal circuits, Circulating blood, Other tissues
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
24-48 hours
Pricing Model
Per project
