About Mcra
MCRA: A Leading Advisory Firm and Clinical Research Organization (CRO) for Medical Technology Developers
MCRA is a renowned advisory firm and Clinical Research Organization (CRO) that provides comprehensive services to medical technology developers. The company has been in the industry for over 20 years, offering expert guidance on regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance.
Regulatory Services
One of MCRA's core areas of expertise is regulatory services. The company helps clients navigate the complex regulatory landscape by providing strategic advice on FDA regulations and other global regulatory requirements. MCRA's team of experts has extensive experience in preparing premarket submissions such as 510(k), PMA, IDE applications, de novo requests, and CE marking applications.
Reimbursement Services
MCRA also offers reimbursement services to help clients secure coverage and payment for their medical technologies. The company's team of experts works closely with clients to develop reimbursement strategies that align with their business objectives. MCRA provides support throughout the entire reimbursement process from coding assistance to payer negotiations.
Clinical Research Services
As a CRO, MCRA provides clinical research services to help clients design and conduct clinical trials that meet regulatory requirements while generating meaningful data. The company's team of experienced professionals includes project managers, clinical research associates (CRAs), biostatisticians, data managers/analysts who work together seamlessly to ensure successful trial execution.
Healthcare Compliance Services
MCRA also offers healthcare compliance services designed to help clients navigate complex legal requirements related to healthcare fraud & abuse laws such as Anti-Kickback Statute (AKS), False Claims Act (FCA), Stark Law among others. The company assists its clients in developing effective compliance programs tailored specifically for their needs while ensuring adherence with applicable laws & regulations.
Quality Assurance Services
Finally yet importantly is Quality Assurance service which ensures that products are manufactured consistently according to established quality standards throughout the product lifecycle from design through post-market surveillance activities including complaint handling & adverse event reporting processes.
Why Choose MCRA?
There are several reasons why you should choose MCRA as your trusted partner in medical technology development:
1) Expertise: With over two decades of experience working with medical technology developers across various therapeutic areas including cardiovascular devices; orthopedic implants; neurostimulation devices; diagnostic imaging systems among others - we have developed deep expertise in navigating complex regulatory pathways while ensuring successful commercialization outcomes.
2) Comprehensive Service Offerings: Our broad range of service offerings allows us to provide end-to-end support throughout the product lifecycle from concept development through commercialization.
3) Client-Centric Approach: We take pride in our client-centric approach where we work collaboratively with our clients' teams towards achieving shared goals.
4) Results-Oriented Focus: Our focus on delivering results ensures that we remain committed towards achieving success metrics aligned with our client's business objectives.
5) Thought Leadership: We stay ahead by keeping abreast of emerging trends within the industry through active participation at conferences/seminars/webinars etc., publishing articles/whitepapers/blogs etc., sharing insights via social media channels etc.
In conclusion,
If you're looking for a trusted partner who can provide expert guidance across all aspects related to medical technology development - look no further than MCRA! With our comprehensive service offerings coupled with deep domain expertise across various therapeutic areas - we can help you achieve your desired outcomes efficiently & effectively!