Medical Device Risk Management Consulting Services

Medical device risk management is an integral part of every phase of your quality management system and it shall be included in all processes. However, special emphasis on implementation of related requirements should be placed on processes that control the design, development, manufacturing, complaint, reporting, vendor controls, training, and management of post-production data. Whether you want to design a new medical device or improve an existing product, your risk management processes and their implementation should be rigorous to ensure the product meets intended purpose and use and if applicable, to obtain FDA or CE Mark approval. 


At MDR Consultants, our risk analysis medical device consulting services involve the identification, understanding, documentation, implementation, control, and .maintenance of processes and outputs that are complaint and conformant to all applicable national and international Risk Management requirements to include FDA regulatory requirements, ISO 13485:2016 and ISO 14971:2019 statutory requirements, MDSAP statutory and regulatory requirements, and EU MDR regulatory requirements. The ultimate objective of any medical device manufacturer is to ensure that their products and services meet their intended use and to ensure their products and services perform as expected while maintaining a preapproved risk-benefit ratio. Through our services, we can help medical device manufacturers identify and classify design, production, and use related risks to ensure that all required mitigation activities are implemented and to ensure they are effective. 


We Handle the Complexities of Risk Management


For most medical device manufacturers, the implementation of risk management processes may appear simple. However, the reality is that the implementation of risk management processes is governed by many statutory and regulatory provisions that requires careful design and implementation of these processes not only to ensure that the medical device meets all pre-determined requirements but also to ensure compliance and conformance to applicable requirements. At MDR Consultants, we have years of hands-on experience in the design, documentation, implementation, control, and maintenance of processes and outputs that meet all applicable requirements to include but not limited to FDA quality systems regulations, to ISO 13485:2016 and ISO 14971:2091 standards, to EU MDR Risk Management Processes Regulatory Requirements, to MDSAP statutory and regulatory requirements.


Control Risks to Improve Overall Medical Device Performance


At MDR Consultants, we employ a collaborative and comprehensive approach that helps risk management processes to be implemented as an important and inherent part of the product life cycles, quality management systems, and supply chain operations designed to deliver ultimate patient safety. 


With our years of experience in compliance and conformance of  quality management systems, we can provide insight into the appropriate identification, management, and mitigation of all the risks related to medical devices produced in the medical devices manufacturing industry. We strive to recognize and mitigate risks early enough and not just as an afterthought after production or product release. Our team of FDA risk assessment medical devices experts will ensure that risk controls are implemented throughout the entire lifecycle of the medical device to ensure that devices. meet pre-established requirements and their intended use. 


Professional Risk Management Services


Quality monitoring, compliance, and risk management are interconnected in the medical devices industry. When you partner with MDR Consultants for your risk assessment of medical devices, you can be assured of the following:

  • You will meet your risk management regulatory and statutory requirements
  • Be conversant with any potential hazards
  • Make data-driven decisions that will enhance risk mitigation and avoidance
  • Meet your business objectives
  • Prepare for growth


To mitigate risks, you need to be aware of potential threats and formulate the right strategy. With years of experience in the industry, we provide effective FDA medical device compliance and conformant solutions that will help you manage risks proactively within the medical device field. At MDR Consultants, our goal is to help every medical device manufacturer to become risk agile and adept.

Quality Management System
ISO Statutory
MDD (European Union)
ANVISA (brasil)
PMDA (Japan)
MDALL (Canada)
TGA (Australia)