The medical device market has tremendously grown and globalized, along with the tremendous increase in medical device usage, has led to a significant increase the complex task of making a medical device safe for human use activity among device manufacturers. Risk Management has become an important competitive tool to gain access to foreign markets.

Risk management standard, adopted by European Committee for Standardization (CEN) as EN ISO 14971:2012, harmonized and it is recommended by the International Medical Device Regulators Forum (IMDRF). In addition to ISO 14971, there are several other key medical device industry standards requiring risk management. The partial list includes:

  • IEC 60601
  • IEC 62366
  • ISO 10993
  • ISO 13485

Our Role

With the new version of ISO 14971:2019 and new risk management Compliance requirements in MDR 2017/745, manufacturers need to be in compliance with new risk management standard requirements for their products for continue to market in their country of interest. MakroCare can assist manufacturers to ease the burden and fasten the compliance process and meet the timelines whenever required.

  • Our goal is to make it easier to understand the risk analysis process
  • Perform the gap analysis of risk files based on device type
  • Write the Risk Management Plan (RMP) for the concerned device
  • Assess its hazards at every stage of device and create the Hazard Analysis Report (HAR)
  • Analysis of Residual Risks and conclude the summary in Residual Risk Report (RRR)
  • Review & update of Risk Management Report (RMR) by evaluating residual risks and collecting production and post-production information
  • Perform the benefit-risk evaluation, which is in line with changing regulatory requirements such as the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

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