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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:

  • Big data analytics
  • Artificial intelligence (AI)
  • Cloud / IOT
  • 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

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

Technical

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

Clinical

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

QA / PMS

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

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