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.
* Expertise in evaluating device interaction with biological systems to ensure safety for human use.
* Services cover the entire product lifecycle, from early development to commercial production and lifecycle management.
* Specialized testing for a wide range of devices including pre-filled syringes, auto-injectors, inhalers, intraocular lenses, and anesthesia/respiratory devices.
* Support for various ISO standards and regulatory guidance, including ISO 10993-1, EN ISO 10993-1, FDA guidance, and ISO 18562.
* Offers consultancy and scientific support throughout the testing process.
**Reputation / proof points**
* Decades of scientific expertise and experience supporting hundreds of medical device programs worldwide.
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.
* Expertise in evaluating device interaction with biological systems to ensure safety for human use.
* Services cover the entire product lifecycle, from early development to commercial production and lifecycle management.
* Specialized testing for a wide range of devices including pre-filled syringes, auto-injectors, inhalers, intraocular lenses, and anesthesia/respiratory devices.
* Support for various ISO standards and regulatory guidance, including ISO 10993-1, EN ISO 10993-1, FDA guidance, and ISO 18562.
* Offers consultancy and scientific support throughout the testing process.
**Reputation / proof points**
* Decades of scientific expertise and experience supporting hundreds of medical device programs worldwide.
Additional information
Cormica's medical device testing services span the entire product lifecycle, encompassing analytical chemistry, microbiology & sterility, physical & packaging testing, and biocompatibility & toxicology. They emphasize generating regulator-ready data to support global submissions and commercialization. For specific device types like pre-filled syringes and auto-injectors, they align testing programs with relevant standards such as ISO 11040, ISO 11608, and USP <1207> to ensure robust performance and safety data. Their approach aims to identify potential risks early in the development process, providing crucial evidence for regulatory approval and lifecycle management.
Key Highlights
-
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.”
-
Provides specialized testing for a wide range of medical devices including pre-filled syringes, auto-injectors, and intraocular lenses.
Source
“Pre-Filled Syringe Testing Auto-Injector Testing Inhaler & OINDP Testing Intraocular Lens Testing”
-
Supports compliance with current regulatory standards and guidance, including ISO 10993-1 2025, EN ISO 10993-1 2020, and FDA guidance September 2023.
Source
“Supporting you with ISO 10993-1 2025, EN ISO 10993-1 2020, FDA guidance September 2023 and ISO 18562-1”
Certifications & Trust Signals
-
Possesses decades of scientific expertise and experience supporting medical device programs.
Source
“Our global team of experienced scientists works across microbiology, analytical chemistry, physical and functional testing, and biocompatibility to deliver coordinated testing programmes.”
-
Supports medical device testing across the entire product lifecycle.
Source
“Medical Device Testing Across the Entire Product Lifecycle”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance testing.
- Companies developing combination products requiring biocompatibility assessment.
- Firms needing lifecycle support for medical devices.
How engagement typically works
- Consultative approach with expert guidance.
- Collaborative testing program development.
- Focus on generating regulator-ready data.
Typical deliverables
- Biocompatibility test reports.
- Toxicological risk assessments.
- Data packages for regulatory submissions.
- Consultancy reports.
Good to know
- Best when specific ISO 10993 standards and device types are clearly defined.
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, Genotoxicity, Systemic toxicity, Biodegradation, Other
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
Yes
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
Toxicology Capabilities:
ISO 10993 testing, biological evaluation, and toxicological risk assessment.
Rush Available:
No
Nda Support:
No
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, EN ISO 10993-1, ISO 18562
Test Types Offered
Biocompatibility testing, Biological evaluation, Toxicological risk assessment, Chemical characterisation, Extractables and leachables, Material analysis, Genotoxicity, Local effects after tissue contact
Contact Types Supported
Surface contact, External communicating, Implant
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
