FDA Compliance and Medical Device Consulting from the Experts
Three decades of experience providing trusted solutions and rapid response to the medical device industry.MEDIcept is uniquely qualified to help you navigate complex regulatory pathways, reducing your business risk and time-to-market, while maximizing your potential for success.
Medical Device Quality Management Systems
Quality System Audits
FDA 483, Warning Letter, Consent Decree
QMS Remediation
Interim Quality Professionals
Post-Market Surveillance
Training and Education
Global Regulatory Strategy and Registration
Regulatory Agency Communication and Meetings
US Regulatory Submission: Pre-sub, 513(g), 510(k), De Novo, PMA
EU-MDR/IVDR Technical Documentation
Clinical Evaluation Report
Regulatory Due Diligence
Interim Regulatory Professionals
Clinical Strategy and Submissions
Trial Start-Up and Management
Site Management and Monitoring
Data Management & Biostatistics
Safety Management
Medical Writing
Decentralized Clinical Trials
Vendor Management and Clinical System Solutions
Clinical Quality Audits
Medical Affairs
Risk Management ISO 14971
DHF Remediation and Development
Medical Device Software Compliance IEC 62304
Usability IEC 62366
Process Validation
Cybersecurity
IEC 60601
Health Economic Analysis
Reimbursement Strategy Roadmap
Comprehensive Landscape Assessment
Fractional Compliance Officer
Compliance Officer Support
Fraud, Waste, and Abuse Prevention
HIPAA Privacy Compliance
Compliance Training
Gap Analysis
Ongoing Monitoring
I need help NOW!
Have you received an FDA 483 notice or a warning letter? Are you struggling to meet new EU MDR or EU IVDR regulations? MEDIcept can help you respond quickly and effectively to help prevent a difficult situation from turning critical.
Need FDA or EU MDR/IVDR audit assistance?
Don't do it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
We’ve helped a wide range of start-ups develop effective regulatory strategies to obtain FDA and EU MDR clearances. We’ll work with you to develop the right domestic or global regulatory strategy for your business to help ensure compliance and product approvals.
What You Can Expect
For Over 25 Years
Our medical device consulting practice has assisted thousands of companies of all sizes with cost-effective regulatory, quality, and clinical services.
Worldwide
MEDIcept is an international medical device and IVD compliance consulting firm with active clients on 6 continents. We have a global clinical team supporting all clinical trials and post-market studies.
Experienced Team
Our experienced team of former FDA, ISO, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial to meet your specific needs.
Clear Navigators
MEDIcept will help you navigate the complex FDA and international regulatory pathways, reduce business risk, and decrease time-to-market while also maximizing the potential for success in the market.
Customized Approach
We recognize that every client and issue are unique. MEDIcept customizes our solutions to fit your business and products.
Successful Approach
With a retention rate of over 90%, our clients trust us and we can promise that you will benefit from working with us through both time and cost savings.