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 and MedTech Contract Research Organization (CRO) and consulting advisory firm. They specialize in regulatory, quality, clinical, and reimbursement services.
**Expertise & scope**
* Offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers.
* Navigates FDA, EU MDR, and global regulatory requirements.
* Provides integrated services including clinical research, regulatory affairs, reimbursement, compliance, and specialized therapy expertise.
* Expertise spans across various medical device lifecycle stages, from pre-clinical testing to post-market surveillance.
* Team includes former FDA reviewers and regulatory agency personnel.
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
* Over 1,000 clients globally.
* Unparalleled PMA track record, including first Orthopedic and Spine De Novo grants.
* Multiple FDA appeal achievements and numerous challenging 510(k) clearances.
* Extensive experience in global regulatory consulting across the US, EU, UK, Japan, Canada, and other international markets.
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm. They specialize in regulatory, quality, clinical, and reimbursement services.
**Expertise & scope**
* Offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers.
* Navigates FDA, EU MDR, and global regulatory requirements.
* Provides integrated services including clinical research, regulatory affairs, reimbursement, compliance, and specialized therapy expertise.
* Expertise spans across various medical device lifecycle stages, from pre-clinical testing to post-market surveillance.
* Team includes former FDA reviewers and regulatory agency personnel.
**Reputation / proof points**
* Over 150 years of combined experience within the organization.
* Offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
* Over 1,000 clients globally.
* Unparalleled PMA track record, including first Orthopedic and Spine De Novo grants.
* Multiple FDA appeal achievements and numerous challenging 510(k) clearances.
* Extensive experience in global regulatory consulting across the US, EU, UK, Japan, Canada, and other international markets.
Additional information
MCRA emphasizes an integrated approach, combining regulatory, clinical, reimbursement, and quality assurance services to streamline the medical device product lifecycle. Their team's deep understanding of regulatory agencies, including the FDA and EU Notified Bodies, allows them to develop efficient and cost-effective pathways for market access. They leverage their extensive network of clinicians and sites to optimize clinical trial enrollment and success rates. The firm's global presence and diverse expertise enable them to support clients in navigating complex international regulatory landscapes, expediting time to market while ensuring sustained compliance.
Key Highlights
-
MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm.
Source
“MCRA is a leading medical device and MedTech Contract Research Organization (CRO) and consulting advisory firm specializing in regulatory, quality, clinical, and reimbursement services.”
-
Offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers.
Source
“MCRA offers comprehensive biocompatibility testing support and strategic guidance for medical device manufacturers navigating FDA, EU MDR, and global regulatory requirements.”
-
Team includes former FDA reviewers and regulatory agency personnel with deep expertise.
Source
“MCRA's team of FDA approval consultants has worked for regulatory agencies as well as those within the private industry...”
-
Possesses over 150 years of combined experience within the organization.
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.”
-
Operates globally with offices in New York City, Washington, D.C., Hartford, CT, and Tokyo.
Source
“We have offices in New York City, Washington, D.C., Hartford, CT, and Tokyo, making us a global leader in this space with more than 1,000 clients around the world.”
Certifications & Trust Signals
-
Extensive track record with FDA submissions including PMA, 510(k), and De Novo grants.
Source
“Unparalleled PMA track record- 1st Orthopedic and 1st Spine De Novo grant- Multiple FDA appeal achievements- Countless 510(k) clearances, many include industries most challenging”
-
Team includes former senior FDA statisticians and former FDA assistant directors, branch chiefs, and reviewers.
Source
“Our team includes former senior FDA statisticians who are well-versed in the requirements needed for FDA submissions...”
-
Supports clients in navigating complex global regulatory climates across multiple geographies.
Source
“MCRA delivers integrated, region-specific regulatory strategies that help you enter global markets faster and stay compliant throughout your product’s lifecycle.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive regulatory and clinical support.
- Companies navigating complex global market access requirements.
- Organizations needing integrated services from pre-clinical to post-market.
How engagement typically works
- Collaborative, working as part of the client's team.
- Strategic advisory and hands-on implementation.
- Integrated service model across multiple disciplines.
Typical deliverables
- Biocompatibility testing strategies and guidance.
- Regulatory submission support (PMA, 510(k), De Novo, CE Mark).
- Clinical trial design, execution, and management.
- Reimbursement and market access strategies.
- Global regulatory compliance plans.
Good to know
- Best when a holistic, integrated approach to medical device development and commercialization is desired.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Canada, Japan, Europe, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18, USP <87>, USP <88>
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity
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 support
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
