Accelerate Resource Deployment Maagement

AccelerateRDM

Accelerate Resource Deployment & Management (AccelerateRDM) drives your projects with specialized, contingent talent, tailored to your needs.

Our cost-efficient solutions ensure compliance with critical regulatory & quality standards, empowering teams to succeed in regulatory, supply chain, quality, and IT initiatives on time and within budget.

Types

Examples of resource options RDM can provide your project, program, or functional team

  • Lead complex medical device projects, ensuring timely delivery within budget and compliance with EU MDR, FDA, and ISO 13485. They create robust plans, coordinate teams, and mitigate risks, driving success in regulatory, quality, supply chain, and IT initiatives using AcceleratePPM frameworks like Gantt Charts and RACI Matrices.

  • Navigate global regulatory requirements, preparing and submitting documentation (e.g., technical files, 510(k), UDI labeling) for EU MDR and FDA compliance. They strategize submissions, liaise with authorities, and ensure audit readiness, enabling seamless market access for medical device projects.

  • Design and execute validation protocols (e.g., IQ/OQ/PQ, CSV) to ensure equipment, processes, and software meet regulatory and quality standards. They deliver compliant documentation for ISO 13485 and FDA audits, supporting quality and IT initiatives with precision and expertise.

  • Implement and maintain quality management systems (QMS), conducting risk assessments (e.g., FMEA) and managing CAPA processes. They ensure compliance with ISO 13485 and FDA QSR, enhancing product quality and audit outcomes in medical device quality and regulatory projects.

  • Optimize supply chain operations, managing supplier relationships and ensuring material traceability for regulatory compliance. They develop procurement plans and mitigate disruptions, supporting efficient, compliant supply chain initiatives for medical device production and distribution.

  • Lead IT projects, such as validated software implementations or infrastructure upgrades, ensuring alignment with regulatory and business goals. They coordinate vendors and deliver compliant solutions, driving success in medical device IT and digital transformation initiatives.

  • Bridge business needs and IT solutions, defining requirements and designing workflows for systems like ERP, MES, or QMS software. They ensure seamless integration and compliance in IT and quality projects, enhancing operational efficiency for medical device firms.

  • Develop and execute test plans for systems, processes, or products, ensuring compliance with FDA and ISO standards. They perform rigorous testing (e.g., software validation, product performance) and document results, supporting IT and quality projects with reliable outcomes.

  • Facilitate adoption of new systems, processes, or organizational changes through stakeholder engagement and training. They ensure smooth transitions in IT (e.g., QMS rollouts) and quality initiatives, boosting team performance and compliance in medical device projects.

Key Features

  • Expert Talent Matching

    We deploy specialized resources like Regulatory Affairs Specialists, Validation Engineers, and IT Technology PMs to fill skill gaps, ensuring seamless delivery of regulatory or IT projects.

    Example: A medical device firm pursuing EU MDR compliance receives a Regulatory Affairs Specialist and Validation Engineer to prepare technical files and validate processes.

  • Flexible Resource Strategies

    Scalable plans, from single Supply Chain Analysts to teams of Program Managers and Quality Engineers, adapt to your project’s scope and budget.

    Example: A life sciences firm implementing QMS software receives a Business System Analyst, IT Technology PM, and OCM Specialist, with flexibility to adjust resources.

  • Seamless Integration Support

    We manage onboarding for resources like Quality Engineers or OCM Specialists, aligning them with your team’s culture and workflows.

    Example: A Testing Resource and Regulatory Affairs Specialist are trained on a client’s QMS tools within days, ensuring immediate productivity.

  • Performance Optimization

    Targeted resources, like Validation Engineers or Supply Chain Analysts, and recovery plans address challenges like non-conformances or missed milestones.

    Example: A struggling program manager receives a Quality Engineer and OCM Specialist with a CAPA plan to resolve audit findings.

  • Monthly Performance Scorecards

    Scorecards assess resources like Business System Analysts or Testing Resources on scope adherence, leadership, and risk management.

    Example: A scorecard identifies a Supply Chain Analyst’s need for improved risk reporting, prompting coaching to enhance outcomes.

  • Industry Best Practices

    Proven tools, like RACI Matrices and Risk Registers, tailored for Validation Engineers or Quality Engineers, ensure compliance with ISO 13485 and FDA standards.

    Example: A RACI Matrix clarifies roles between a Project Manager, Quality Engineer, and Testing Resource on a regulatory submission project.

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Value

Benefits

  • Cost Efficiency: Contingent resources, from Supply Chain Analysts to Validation Engineers, reduce overhead while delivering specialized skills.

  • Flexibility: Scalable solutions adapt, whether deploying a Regulatory Affairs Specialist or a team of Program Managers and Quality Engineers.

  • Speed: Rapid deployment of Business System Analysts or Testing Resources keeps projects on schedule.

  • Confidence: Hands-on support and performance tracking empower teams in regulatory, quality, supply chain, or IT initiatives.

  • Compliance Focus: Experts ensure alignment with EU MDR, FDA, and ISO 13485 requirements.

Who is RDM for?

  • Managers New to Projects: Leaders in regulatory or IT roles needing support from Regulatory Affairs Specialists or IT Technology PMs.

  • Teams with Skill Gaps: Organizations requiring Validation Engineers or Supply Chain Analysts without permanent hires.

  • Struggling Project Managers: Leaders facing non-conformances or supply chain issues, supported by Quality Engineers or OCM Specialists.

  • Regulated Industries: Companies needing compliance expertise from Regulatory Affairs Specialists.

Optional Sustainment Support

AccelerateRDM offers optional sustainment check-ins, scheduled at your discretion (e.g., quarterly), to ensure long-term success. These check-ins:

  • Review performance of resources like Quality Engineers or OCM Specialists, ensuring alignment with project and compliance goals.

  • Provide guidance on challenges, such as adding a Testing Resource for a new regulatory phase.

  • Recommend adjustments to maintain efficiency and quality.

Example: A quarterly check-in identifies a need for an additional Regulatory Affairs Specialist to support a new FDA submission, deployed within 24 hours.

Why choose

RDM

Services?

AccelerateRDM is a service dedicated to delivering high-impact medical device and life sciences projects.

Our diverse talent pool—Program Managers, Regulatory Affairs Specialists, Validation Engineers, Quality Engineers, Supply Chain Analysts, Business System Analysts, IT Technology PMs, Testing Resources, and OCM Specialists - combined with flexible strategies and performance tracking, ensures success without the complexity of traditional resourcing. Focused on regulatory, quality, supply chain, and IT initiatives, we align with EU MDR, FDA, and ISO 13485 standards, keeping your projects on time and within budget.

AccelerateRPM offers an integrated value proposition by combining AccelerateRDM’s specialized talent with our AcceleratePPM services. Clients sourcing RDM resources gain access to tailored project management frameworks, tools (e.g., Gantt Charts, RACI Matrices), and training to enhance project execution. This complementary approach ensures your team not only has the right experts but also the processes to maximize value, providing a competitive edge over firms offering standalone resourcing.