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Red Care Medical
Regulatory and Quality Consulting Experts
Red Care Medical has over 30 years of experience providing expert regulatory and quality consulting services to clients in the pharmaceutical and medical industries. Our seasoned professionals specialize in helping businesses navigate complex regulatory requirements, implement robust quality management systems, and ensure compliance with industry standards. Having the right medical device regulatory consulting partner at the right time is invaluable in achieving compliance and market access.
As experts in driving successful medical device and IVD regulatory submissions, Red Care Medical excels in managing daily interactions with international authorities, including the U.S. FDA, Japan’s PMDA, Europe’s Notified Bodies, and China’s NMPA.
We offer a comprehensive range of medical device and IVD regulatory consulting services, covering the entire spectrum from product design and development to post-market support. Our regulatory consultants develop and implement global strategies tailored to accelerate your commercialization efforts—whether it's Notified Body selection, Pre-IDE preparation, or Advisory Panel Meetings. Our goal is to help you reach the market faster, ultimately enabling you to make a more immediate impact on patient safety and healthcare.
Our Services
US FDA
Quality Compliance
Quality Compliance
- Expert Team: Red Care Medical's U.S. Consulting Team includes former U.S. FDA staff and industry experts, involved in over 100 FDA Pre-Submission applications, helping accelerate clearance and approvals of innovative technologies.
- Comprehensive Services: We offer a wide range of U.S. FDA regulatory consulting services, including 510(k) sub
- Expert Team: Red Care Medical's U.S. Consulting Team includes former U.S. FDA staff and industry experts, involved in over 100 FDA Pre-Submission applications, helping accelerate clearance and approvals of innovative technologies.
- Comprehensive Services: We offer a wide range of U.S. FDA regulatory consulting services, including 510(k) submissions, Breakthrough Device Program submissions, De Novo submissions, PMA submissions, Q-Submissions, and more, guiding clients through the entire product development process.
- Regulatory Strategy: Our team helps clients navigate FDA regulations by developing robust submission strategies, addressing key considerations such as product classification, applicable standards, required testing, and clinical data.
- Clinical Studies and IDE Submissions: We assist in determining significant vs. non-significant risks, managing clinical studies, and facilitating IDE submissions when required.
- Post-Approval Support: Red Care Medical offers ongoing support, including annual FDA reports, PMA supplements, and strategies for addressing FDA 483 observations and warning letters.
Quality Compliance
Quality Compliance
Quality Compliance
- Quality Management System (QMS) Importance: The development, implementation, adherence, and continuous improvement of a compliant QMS are crucial for ensuring patient safety, delivering high-quality products, and driving company value.
- Comprehensive Quality Support: Red Care Medical provides expert support to medical device manufacturers i
- Quality Management System (QMS) Importance: The development, implementation, adherence, and continuous improvement of a compliant QMS are crucial for ensuring patient safety, delivering high-quality products, and driving company value.
- Comprehensive Quality Support: Red Care Medical provides expert support to medical device manufacturers in complying with U.S. FDA Quality System Regulation (QSR), EU Medical Device Regulation (MDR), and ISO standards.
- Tailored Solutions: Our global Quality Team, with experience ranging from Fortune 100 companies to start-ups, offers customized medical device quality systems that align with the specific needs, products, and culture of each manufacturer.
- Key Services:
- Audits and Gap Assessments for FDA 21 CFR Part 820 (QSR), ISO 13485, ISO 9001, MDR, and Medical Device Single Audit Program (MDSAP)
- Assistance in resolving identified gaps
- Change Control and Corrective and Preventive Action (CAPA), including Root Cause Analysis
- Design Controls and Design History File development or assessments
- Device Master Record (DMR) development or assessments
- Health Hazard Evaluation (HHE)
- Internal audits and Pre-BIMO/Mock BIMO inspections
- Process validation and Quality system development/implementation
- Quality system mock inspections for U.S., EU, China, and Japan
- Quality system remediation and Risk Management Program development
- Supplier audits and Standards assessments
Medical Writing
Quality Compliance
Medical Writing
- Comprehensive Medical Writing Services: Red Care Medical offers a wide range of specialized report writing, manuscript submission, and evidence communication services tailored for medical device manufacturers and global regulatory entities.
- Expert Team: Our team consists of expert doctors, engineers, and physicists with extensive experienc
- Comprehensive Medical Writing Services: Red Care Medical offers a wide range of specialized report writing, manuscript submission, and evidence communication services tailored for medical device manufacturers and global regulatory entities.
- Expert Team: Our team consists of expert doctors, engineers, and physicists with extensive experience in numerous submissions.
- Regulatory Compliance Expertise:
- Skilled in identifying, organizing, interpreting, and presenting clinical data.
- Expertise in complying with Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), MEDDEV 2.7.1 rev. 4, and other regulatory guidelines.
- Collaborative Approach:
- Work closely with Red Care Medical’s Regulatory, Clinical, and Biostatistics Teams.
- Highly responsive to individual client needs.
- Provide personalized plans to guide future compliance activities.
- Risk Management Support: We assist in conducting risk assessments and developing comprehensive risk management plans and files to ensure compliance with ISO 14971.
CE Mark Support
MDR - Clinical and PMS
Medical Writing
- CE Mark Solutions: Red Care Medical provides expert assistance for medical device manufacturers launching new devices in Europe or transitioning legacy devices from MDD to MDR, leveraging the experience of former Notified Body staff and industry experts.
- Key Services:
- Regulatory Consulting:
- Drug/Device Combination Device Support under Rule
- CE Mark Solutions: Red Care Medical provides expert assistance for medical device manufacturers launching new devices in Europe or transitioning legacy devices from MDD to MDR, leveraging the experience of former Notified Body staff and industry experts.
- Key Services:
- Regulatory Consulting:
- Drug/Device Combination Device Support under Rule 14
- In Vivo Origin Products Compliance (EU Regulation 722/2012 & EN ISO 22442)
- Conformity Assessment under MDR 2017/745
- Device Classification and Regulatory Pathway Consulting
- ISO 14971 Risk Management Support
- MDR Technical Documentation Gap Analysis
- Clinical Evaluation Reports (CER)
- Notified Body Observations and Non-Conformity Responses
- Reprocessing of Disposable Products under MDR
- UKCA Marking and UDI Guidance
- Drug/Device Combination Devices:
- Assistance with medicinal component consultation dossiers under Rule 14, including experience with products such as wound dressings and drug-coated stents.
- In Vivo Origin Products:
- Expertise in regulatory compliance for devices utilizing In Vivo tissues, ensuring adherence to EN ISO 22442 and Commission Regulation 722/2012.
- Device Classification:
- Guidance on correct device classification and developing regulatory pathways under MDR 2017/745 or IVDR 2017/746, considering complex regulatory requirements.
- Reimbursement Strategy:
- Integration of market access and reimbursement strategies early in the CE Mark process, with expert guidance on navigating EU member state health technology assessments and reimbursement rules.
- ISO 14971 Risk Management:
- Comprehensive risk management support, including planning, conducting risk analyses, and integrating risk management outputs into Post-Market Surveillance (PMS) procedures.
- Technical Documentation:
- Assistance with compiling, reviewing, and submitting technical documentation for regulatory submissions, ensuring compliance with applicable standards and GSPR requirements.
- Notified Body Selection:
- Expert advice on selecting the right Notified Body based on technology, regulatory requirements, and market access goals, ensuring timely and successful CE marking.
- Documentation and Regulatory Support:
- Services include identifying applicable standards, preparing clinical evaluations, developing post-market surveillance documentation, and responding to Notified Body questions.
MDR - Clinical and PMS
MDR - Clinical and PMS
MDR - Clinical and PMS
- Continuous Compliance: Under the EU Medical Device Regulation (MDR), maintaining CE Marking requires ongoing assessment of device safety and performance through Post Market Clinical Follow-up (PMCF).
- Strategic PMCF Support: Red Care Medical can help you strategize which data to collect, the best methods for collecting it, and how to prepar
- Continuous Compliance: Under the EU Medical Device Regulation (MDR), maintaining CE Marking requires ongoing assessment of device safety and performance through Post Market Clinical Follow-up (PMCF).
- Strategic PMCF Support: Red Care Medical can help you strategize which data to collect, the best methods for collecting it, and how to prepare a robust PMCF report that aligns with your Notified Body’s expectations.
- Tailored Assistance:
- Whether your device has been on the EU market for decades or is newly seeking CE Marking certification, Red Care Medical’s regulatory and medical writing teams are ready to support you.
- Assistance includes gathering, assessing, and evaluating all necessary clinical evidence for both premarket submissions and postmarket compliance.
- Integration with Post Market Surveillance (PMS): PMCF is a crucial part of your overall Post Market Surveillance activities, ensuring ongoing compliance and safety in the EU market.
Digital Health and SaMD
MDR - Clinical and PMS
MDR - Clinical and PMS
- Expertise in Software as a Medical Device (SaMD): We have deep expertise in bringing SaMD to market and maintaining compliance with regulatory requirements.
- Comprehensive Support:
- Provide consulting on software validation.
- Assist with FDA submissions.
- Offer guidance every step of the way, from development to regulatory approval.
- Diverse Capabi
- Expertise in Software as a Medical Device (SaMD): We have deep expertise in bringing SaMD to market and maintaining compliance with regulatory requirements.
- Comprehensive Support:
- Provide consulting on software validation.
- Assist with FDA submissions.
- Offer guidance every step of the way, from development to regulatory approval.
- Diverse Capabilities:
- Support for SaMDs, clinical decision support tools, and digital devices.
- Ensure cybersecurity compliance to meet regulatory standards.