SaMD consultants

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Software as a
Medical Device |
SaMD
Consultant

Fast. Agile. Staffing

elemed is a comprehensive MedTech total talent management agency specialising in services and solutions tailored for the medical device and diagnostic industry, with a particular emphasis on Software as a Medical Device (SaMD). We help software as a medical device companies to find exceptional SaMD consultants who are highly experienced in compliance. With a wealth of experience spanning over five decades, the elemed team collaborates closely with talented consultants worldwide. We have a market-leading network of SaMD consultants who have extensive backgrounds in regulatory, quality, clinical, digital health, artificial intelligence (AI) and cybersecurity.  This means that when you approach us with your project, we can quickly find brilliant consultants to keep your projects moving forward to successful completion.

Our consultants have experience with:

  • Regulatory Compliance: Adherence to regulations and standards set by regulatory bodies such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), and others depending on the target market

     

     

  • Quality Management System (QMS): Implementation of a robust quality management system compliant with standards such as ISO 13485, which ensures consistent design, development, production, installation, and delivery of medical devices

     

     

  • Risk Management: Identification, assessment, and mitigation of risks associated with the software, including cybersecurity risks, data privacy concerns, and potential harm to patients

     

     

  • Clinical Evaluation: Conducting clinical evaluations to demonstrate the safety, efficacy, and performance of the software in the intended use environment, including clinical trials or studies where applicable

     

     

  • Software Development Lifecycle (SDLC) Compliance: Adherence to standards such as IEC 62304 for medical device software lifecycle processes, including requirements specification, design, implementation, verification, validation, and maintenance

     

     

  • Usability Engineering: Ensuring the software is designed and developed with consideration for usability, user experience, and human factors engineering principles to minimise the risk of user error and enhance user acceptance

     

     

  • Documentation and Traceability: Maintaining comprehensive documentation throughout the software development lifecycle, including design documents, risk management files, and traceability matrices to demonstrate compliance and facilitate regulatory audits

     

     

  • Post-Market Surveillance: Implementing systems for monitoring and reporting adverse events, complaints, and other post-market surveillance data to ensure ongoing safety and performance of the software

     

     

  • Labelling and Instructions for Use (IFU): Providing clear and accurate labelling and instructions for use accompanying the software to ensure proper usage and minimise risks to patients and users

     

     

  • Cybersecurity: Implementing cybersecurity controls and measures to protect the software from unauthorised access, data breaches, and other security threats, in line with standards such as ISO 27001 and guidance from regulatory agencies

     

     

  • Data Privacy and Protection: Ensuring compliance with data protection regulations such as GDPR (General Data Protection Regulation) and HIPAA (Health Insurance Portability and Accountability Act) to safeguard patient data and privacy

     

     

  • Interoperability and Standards Compliance: Ensuring compatibility and interoperability with other medical devices and healthcare systems through adherence to relevant standards and interoperability frameworks

     

     

  • Software Validation and Verification: Conducting thorough validation and verification activities to ensure the software meets its intended requirements and specifications, including testing for functionality, performance, and interoperability

     

     

  • Change Control and Configuration Management: Implementing processes for managing changes to the software, including version control, configuration management, and change control procedures to maintain the integrity and reliability of the product

     

     

  • Continual Improvement: Establishing mechanisms for monitoring performance, collecting feedback, and implementing improvements to the software and associated processes over time to enhance safety, efficacy, and quality

 

Find out more about how we approach supporting your compliance projects with SaMD consultants  →

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How does elemed find the best consultants?

elemed proudly maintains an extensive network of industry-leading medical device and diagnostics consultants, including numerous experts in SaMD who are renowned for their depth of knowledge and experience. Our dedicated talent management team is committed to comprehensively understanding your software as a medical device project requirements and curating an exceptional shortlist of consultants precisely tailored to your needs, all within a swift 48-hour timeframe from your initial inquiry. Furthermore, our streamlined process ensures that your selected consultant can commence work within an average of just 10 days from our initial conversation, facilitating a prompt project kickoff and averting potential delays.

We have partnered with a diverse range of businesses seeking consultants specialised in SaMD, including:

  • Large global corporations
  • Medical device manufacturers
  • Emerging medical device startups
  • Notified Bodies
  • Consulting firms
  • Contract research organisations

     

With over 50 years of collective experience, our total talent management team collaborates closely with consultants and software as medical device companies on a daily basis, meaning we have a deep knowledge of the intricacies of SaMD and the skills and experience needed for a variety of compliance projects. We collaborate with exceptional consultants recognised as subject matter experts across regulatory affairs, quality assurance, clinical affairs, digital health, AI, cybesecurity and more for SaMD, who are available to start work on your project right now. Our support extends globally, encompassing diverse geographical regions including:

      • DACH
      • Scandinavia
      • Northern Europe
      • Southern Europe
      • France
      • BENELUX
      • US

What skills and experience do your SaMD consultants have?

The consultants within our network bring a broad spectrum of skills and experiences in medical devices, diagnostics and SaMD, ensuring that we can find the perfect candidate to meet your project needs, no matter how specific or niche they may be. Our consultants provide flexible support tailored to your project’s timeline and duration. Moreover, our consultants are ready to hit the ground running, with most commencing work within about 10 days of your initial engagement with us.

Aeas our consultants can support with:

  • Global regulatory strategy support
  • Gap assessments of technical documentation (e.g. CE, 510(k); De Novo; PMA, etc)
  • Support Design Control, DHF creation, Risk Management, EUDAMED (UDI), etc
  • EU CE mark NB/CA submissions (significant changes, variations and amendments)
  • SME support (e.g. therapeutic area, regulator experience, etc)
  • EU MDR/IVDR – Sustaining/Maintenance programs post CE approval
  • NB/CA audit questions response support
  • FDA 483 and warning letter responses
  • Project File/Device History File remediation
  • CE mark Technical Documentation remediation – EU MDR/IVDR
  • Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PERs)
  • PMS activity (PMS Plans, PMCF, PSUR)
  • Summary of Safety and Clinical Performance (SSCP)
  • Summary of Safety and Performance (SSP for IVDs)
  • MDR and IVDR Clinical Support
  • Sustaining and Maintenance CER/PERs/PMS
  • ISO 13485, 21 CFR 820 and MDSAP compliance support
  • Economic Operator support (Mfg, Importer, distributor, packaging, supplier, etc)
  • CAPA/NCR services
  • Complaint handling and recalls
  • Process QMS improvement
  • Supplier Auditing/Assessments
  • Internal Auditing
  • Pre-FDA Audit Assessments
  • Pre-MDSAP Audit Assessment
  • MDR/IVDR Audit Assessment
  • Audit readiness (SME, Corporate, etc)
  • Validation Master Plan/Report review and remediation
  • IQ, OQ, PQ validation
  • Support FAT and SAT Process validation (Packaging, Sterilisation, CSV, etc)
  • Performance Improvement (Kaizen, Mfg process improvement, Value Stream Mapping, etc)
  • ISO 14971 Risk management framework and risk assessment
  • dFMEA, pFMEA, uFMEA
  • Risk controls, mitigation, and avoidance
  • Design verification and activities
  • Full Project life cycle management
  • Project planning and KPI
  • Project tracking to scope, milestone, budget, quality standards, etc Working/Steering/Executive Group participation
  • Continuous improvement on standard methodology, tools, management, talent development, etc

What other areas do elemed's consultants specialise in?

    • Class I, II, III medical devices
    • Software as a medical device and digital health
    • Active and non-active medical devices
    • Diagnostics
    • Regulatory, quality and clinical
    • Data science, digital health and AI
    • Cybersecurity in MedTech
    • CDx
    • Sustainability
    • Microbiology and toxicology

Why work with an SaMD consultant through elemed?

We collaborate with renowned consultants who are authorities in software as a medical device. They are proficient in global medical device regulations and regulatory requirements including software, SaMD development validation, design control, risk management, cybersecurity and privacy, QMS, managing feedback from competent authorities and notified bodies, and many other areas.

We typically share a curated shortlist of excellent consultants within 48 hours of speaking, maintaining an average ratio of 3 CVs to 1 placed consultant. Moreover, our services provide a more cost-effective solution compared to conventional options in software as a medical device consulting.

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