Our Services

Define, develop, and execute customized regulatory pathways that meet regional requirements and accelerate
time to market.

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• Global Regulatory Strategy Development

  • Customized strategies for medical devices and diagnostics across U.S., EU, and international markets.

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• International Regulatory Submissions

  • Preparation and support for FDA 510(k), De Novo, PMA, Q-Submissions, and EU MDR/IVDR technical documentation.

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• Regulatory Authority Engagement

  • Direct communication with the FDA, Notified Bodies, Authorized Representatives, and Competent Authorities.

Ensure your QMS aligns with regulatory expectations and industry best practices for medical devices, diagnostics, and software.

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• QMS Development

  • Fit-for-purpose processes that support compliant product development and manufacturing—ensuring safety, performance, and regulatory alignment.

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• Process Optimization & Quality Improvement

  • Targeted improvements to development, manufacturing, and post market processes, including risk management, design controls, process and computerized software validation, and other quality-critical processes.

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• Gap Assessments & Audit Readiness

  • Comprehensive reviews of internal processes and documentation, and audit-readiness preparation for FDA inspections, Notified Body audits, and MDSAP assessments.

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• Post Market Support

  • Analysis, remediation and reporting of complaints, CAPAs, field actions, design changes, and post market surveillance reports.

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• Implementation of eQMS systems

  • Configuration, implementation, and automated validation of eQMS, PLM, MES, CMMS, and other software that supports your quality activities.

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• Training & Capability Building

  • Foundational training programs and specialized training to equip your team with the knowledge and tools to sustain compliance and drive quality at every stage.

Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) present unique regulatory and quality challenges. Quarem provides decades of software expertise needed to bring compliant and secure medical device software to market.

 

Our capabilities include:

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• SaMD/SiMD Regulatory Strategy

  • Support aligned with FDA, MDR/IVDR, and IMDRF for standalone software and embedded systems, including AI/ML and connected technologies.

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• Computer Software Assurance for Production and Quality System Software​

  • Risk-based software validation aligned with FDA, GAMP 5 and IMDRF guidances.​

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• Premarket Submissions & Documentation

  • End-to-end assistance with 510(k), De Novo, Q-Submissions, and EU MDR/IVDR submissions, addressing all software-specific requirements.

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• Software Standards

  • Implementation of frameworks based on IEC 62304 (software lifecycle), IEC 82304 (SaMD), IEC 62366 (usability) and ISO 14971 (risk management).

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• QMS for Software Products

  • Quality Management Systems aligned with ISO 13485 and tailored to modern software development practices.

Achieve and maintain compliance with international standards across diverse global markets through expert guidance and strategic solutions.

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• ISO 13485 & ISO 9001

  • Implementation and optimization of quality management systems tailored to your product classification and market requirements.

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• CE Marking Under MDR & IVDR

  • Comprehensive support for technical documentation, GSPR alignment, and Notified Body interactions to secure CE certification and transitions from Medical Device Directive (MDD) and In-Vitro Diagnostics Directive (IVDD).

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• MDSAP & Rest of the World (RoW) Market Requirements

  • Preparation for multi-country audits and regulatory compliance beyond the U.S. and EU.

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• IEC 62304 and IEC 82304 Compliance

  • Implementation of a compliant software development lifecycle (SDLC), including risk classification, software verification and validation, documentation, and traceability.

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• ISO 14971 and IEC 62366

  • Integration of product safety, risk management, and usability standards specific to medical devices.

Navigate complex FDA requirements for medical devices, in vitro diagnostics, and medical device software—including digital health products—with clarity and confidence.

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• 21 CFR Part 820 & Related U.S. Regulations

  • Compliance strategies to meet Quality System Regulation (QSR) requirements and product-specific obligations.

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• FDA Remediation & Enforcement Support

  • Strategic planning and response for FDA 483 observations, Warning Letters, and compliance commitments.

Flexible resourcing with subject-matter experts who understand the complexities of medical technology and regulatory science—helping you achieve your regulatory and quality objectives.

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• Outsourced Quality & Regulatory Support

  • Staff augmentation for short-term needs, expanded bandwidth during critical projects, or long-term capability growth.

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• Supplier Management & Contractual Oversight

  • Expert guidance on supplier qualification, controls, auditing, and quality agreements.

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• Confidential Strategic Consultation

  • Customized advisory services addressing unique regulatory, operational, or quality system challenges across device, diagnostic, and software portfolios.