Software as Medical Device/IVD

Scientific and technological breakthroughs, including sophisticated data collection and 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