MCRA
MCRA, LLC
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services. MCRA offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.
MCRA is a premier medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm that provides integrated regulatory, quality, clinical, and reimbursement services. With deep expertise in biocompatibility testing and ISO 10993 compliance, MCRA helps medical device manufacturers navigate complex regulatory pathways including FDA 510(k), PMA, EU MDR, and international submissions. The firm offers strategic consulting on biocompatibility testing strategies, test plan development, and regulatory submission support. MCRA's team of experienced regulatory professionals works closely with clients to ensure efficient and compliant biocompatibility programs that meet global regulatory standards.
About
**Who they are**
MCRA is a leading medical device consultant and clinical research organization.
**Expertise & scope**
* Expertise in Biocompatibility Testing (ISO 10993).
* Comprehensive understanding of medical device regulatory pathways.
**Reputation / proof points**
* Recognized as a leading consultant in the medical device industry.
MCRA is a leading medical device consultant and clinical research organization.
**Expertise & scope**
* Expertise in Biocompatibility Testing (ISO 10993).
* Comprehensive understanding of medical device regulatory pathways.
**Reputation / proof points**
* Recognized as a leading consultant in the medical device industry.
Additional information
When engaging MCRA for Biocompatibility Testing, buyers can expect a structured approach to navigating the ISO 10993 standards. The organization focuses on providing clear guidance and execution for medical device manufacturers seeking to demonstrate product safety. Their consultancy services aim to streamline the testing process, ensuring that all relevant aspects of biocompatibility are addressed according to international requirements. Buyers should be prepared to provide detailed information about their device's intended use and material composition to facilitate accurate testing protocols and reporting.
Key Highlights
-
MCRA has over 150 years of combined experience within their organization as a leading CRO and advisory firm.
Source
“With more than 150 years of combined experience within our organization, we stand as the leading privately held diagnostics, biologics and medical device CRO and advisory firm.”
-
Their team includes biocompatibility scientists and toxicologists with past work experience at both FDA and Industry.
Source
“With a team of experienced biocompatibility scientists and toxicologists with past work experience at both FDA and Industry, we are well-versed in global biocompatibility requirements”
-
MCRA specializes in comprehensive services for medical device biocompatibility, empowering confident market entry.
Source
“MCRA specializes in comprehensive services to ensure your medical devices are biocompatible, empowering you to confidently bring safe and effective products to market.”
-
They possess expertise in developing EU MDR benefit-risk assessments for CMR substances.
Source
“Our team has extensive knowledge and experience in developing these assessments for the EU MDR and is an author in a series of recent publications that review the reproductive toxicity and carcinogenic potential of Cobalt-containing alloys and evaluate their benefits and risks.”
Certifications & Trust Signals
-
MCRA is a leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.
Source
“MCRA is the leading U.S. Regulatory Advisor for the Medical Device and Biologics industries.”
-
They have a track record of multiple FDA appeal achievements and numerous 510(k) clearances.
Source
“Multiple FDA appeal achievements - Countless 510(k) clearances, many include industries most challenging”
HQ:
United States
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Canada, Japan, Europe, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility
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)
Is Accredited:
Yes
Toxicology Capabilities:
In-house toxicology expertise for risk assessment and test strategy development
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Regions Served:
United States, Europe, Asia
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility Testing
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
3-5 business days
Pricing Model
Custom
