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Software as Medical Device/IVD Medical Device

Software as Medical Device (SaMD)

Software as Medical Device/IVD Medical Device

Scientific and technological breakthroughs, including sophisticated data collectionand analytics, have combined to create more personalized, patient-centric treatment options and revolutionary applications for medical therapies and interventions.

Transformative technologies, including the following, are the next frontier formed tech:

  • Arrow Big data analytics
  • Arrow Artificial intelligence (AI)
  • Arrow Cloud / IOT
  • Arrow Software as a medical device (SaMD)

MakroCare is a leading services provider supporting software based devices and diagnostics.Either as full service end-to-end or functional services, we partner with companies in supporting medical device software including Software as a Medical Device (SaMD), Software in a Medical Device (SiMD) and Accessories to medical devices composed of software.

Regulatory Affairs

  • Arrow Regulatory strategy & planning
  • Arrow Pre-market product registration requirements/ submissions
  • Arrow Assist in the Qualification and Classification of software as per Regulation(s)
  • Arrow Gap Analysis/ update/ creation of Technical Documentation
  • Arrow Initial Registration, Establishment Registrations & Listing
  • Arrow Life Cycle Management
  • Arrow Advice on Supply Chain Obligations& Contracts
  • Arrow Labeling Strategy
  • Arrow Labeling review/ update/ creation and Design labels
  • Arrow Promotional Materials Review

Technical

  • Arrow Gap Analysis with corresponding regulatory requirements
  • Arrow Assistance in software engineering process (LCM, Risk management, software verification and validation in compliance to ISO 62304)
  • Arrow Guidance on developing a cyber-security risk management process
  • Arrow Design and Maintenance of software planning
  • Arrow Integrating usability engineering process/human factors into software development (UER/ UOUP writing)
  • Arrow Biological Risk Assessment
  • Arrow Biological Evaluation Plan/Report writing
  • Arrow Specific approach and activities associated with software validation and revalidation

Clinical

  • Arrow Establishment of Clinical Evaluation Process
  • Arrow Clinical Plans & Reports (CEAR, CEP, CER)
  • Arrow Methodological approach in the generation of Clinical Evidence required based on category
  • Arrow Literature Review & PMS data
  • Arrow Risk/Benefit Analysis
  • Arrow PMCF Plan & report
  • Arrow Monitoring & Evaluation of real-world clinical performance and post-market risk management

QA / PMS

  • Arrow Plan, Write/Review of Quality documents (Manuals/SOPs)
  • Arrow Advice on HA/NB process
  • Arrow Software Quality Planning
  • Arrow Software Development Process
  • Arrow Establishing QMS Process aligned with FDA QSR, QMS ISO 13485
  • Arrow Vigilance Search
  • Arrow Post Market Management (Recording of device defects or malfunctions, recalls, Field Safety Corrective Actions and serious injuries etc)
  • Arrow PMS Plan / Report / PSUR
  • Arrow Safety Reports & HA/NB Submissions

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