ISO 14971 Risk Management Consulting for Medical Device Companies

What does ISO 14971 call for?
Exactly how do I implement ISO 14971?
Just how do I apply the risk management system and concepts to my product?

Medical device regulators in almost all major markets identify that risk management concepts need to be made use of to identify as well as address security issues of devices throughout their life cycle. ISO 14971 is formally identified as the de facto risk management criterion by regulatory authorities in the US, Europe, Canada, Australia, and more. ISO 14971 enhances your company’s ability to decrease unpredictability, and also your capability to accomplish the crucial purpose of guaranteeing device security and also performance.

What does ISO 14971 require?
ISO 14971 helps your business develop, paper, and keep a systematic process to manage the risks connected with using a medical device. This consists of continuous tracking of field experience, consequently embracing the concepts of constant enhancement and state-of-the-art device performance. To take full advantage of performance of your risk management system, ISO 14971 can and should be an essential part of your quality monitoring system (QMS) as needed by ISO 13485.

Particular requirements of ISO 14971 consist of:

  • Provision of sufficient sources
  • Project of qualified employees
  • Establishment of a plan for hazards acceptability standards
  • Management reviews of the Risk Management System
  • With these components in position, ISO 14971 includes demands customized to supply the risk control required for an offered medical device. These demands include:
  • Risk management planning
  • Hazard evaluation of the medical device
  • Assessment of the determined risks
  • Identification and application of controls for the risk
  • Examination of general recurring risk
  • Risk management documents (paperwork).
  • Surveillance production and also post-production information to ensure safety.

Just how to implement ISO 14971 for medical device risk management.
While the quality management system and also risk management systems can stand alone, it is helpful to combine them into a solitary, integrated system. If you are carrying out an ISO 13485 QMS or currently have one in position, we can assist with incorporating ISO 14971 right into your existing QMS. Our execution procedure includes 2 parts:.

Tip One: Gap Analysis.
Our specialist professionals perform an on-site or off-site assessment of your current procedures as well as risk management papers to assess your present degree of compliance with ISO 14971.
Tip Two: Establish Risk Management procedure and Risk Management File.
Based on our gap analysis and also needs for your device type, we design and record a system for managing as well as evaluating danger that satisfies the requirements for ISO 14971.
We can use the two-step procedure to concentrate on ISO 14971 if you have different risk management as well as top quality monitoring systems. Additionally, we can tailor an evaluation and assistance for specific process elements (e.g., risk evaluation, post-market surveillance) as needed.

Once your risk management system remains in area, Kobridge can guarantee all employees comprehend how they contribute to effective risk management and also top quality administration.

Applying risk management with the device life cycle.
Your risk management system need to function properly to satisfy consumer and also regulative demands. Nonetheless, this can be a challenging task as devices become extra sophisticated as well as regulator expectations end up being more strenuous. We can sustain your team’s risk management efforts for the entire product lifecycle, from first item principle with end of life:.

Preparation– Defining the range of risk management tasks and integrating with your QMS processes is the primary step to applying an efficient risk management system. We can direct you through the needs for defining duties and authorities, developing threat approval requirements, and establishing a system for collection and review of production and also post-production information, as well as much more.
Paperwork– We recognize with a variety of styles as well as approaches for paperwork that shows traceability for all threats. We understand how each component incorporates with the overall risk management process to recognize prospective spaces or opportunities for improvement when sustaining product documents initiatives.
Risk Analysis/Assessment– Our risk management experts have the competence to support different risk analysis/assessment steps, including helping with a clear understanding of the Intended Use, Users, as well as Use Environment, as well as a detailed understanding of the characteristics connected to safety. We can help define prospective threats for consideration as well as help with the process of danger evaluation and also assessment.
Risk Control– Risk Control consists of the process of recognizing means to lower specific risks with a repetitive process, whether the threat is connected with product design, production, outsourced processes, personnel skills, or other resources. Our risk management experts can help with discussions as well as give an independent, unbiased viewpoint throughout this task.
Manufacturing and also Post-Production Information– Our risk management specialists comprehend the expectations for post-market surveillance (PMS) under the Medical Devices Regulation (MDR 2017/745) as well as In Vitro Diagnostic Devices Regulation (IVDR 2017/746); we can supply insight right into these needs to guarantee you efficiently monitor your device’s area performance.
Choose Kobridge as your ISO 14971 consultants for medical device risk management.
Our professionals understand what it requires to attach and also handle procedure communications to create the wanted result: person safety. We can help you assess your top quality system, apply ISO 14971, and also abide by risk management needs in markets around the globe in an efficient, economical means. We can aid to bridge the gap between the apparently abstract risk management principles as well as item layout input and also result demands.

Right here’s what you get when you choose Kobridge:.

Our consulting group has actually carried out hundreds of FDA QSR as well as ISO 13485 top quality systems at medical device manufacturers of a wide range of Class I, II, as well as III devices.
We have extensive experience integrating ISO 14971 right into existing ISO 13485 and also FDA GMP QMSs.

Our risk management professionals have extensive item expertise covering a wide range of practical as well as technological disciplines (e.g., human factors engineering, software development engineering).
Ask us about ISO 14971 implementation and risk management seeking advice from services for medical devices.

Last, ISO 14971 has strong connection with other standards. First of all ISO 13485 because this standard has numerous references to risk management and therefore ISO 14971 methods should be implemented. Other standards have also strong links with ISO 14971. To name a few: ISO 10993-1 (biological evaluation of medical devices), IEC 62344 (medical device software) or IEC 62366-1 (usability).

If you need some help for the implementation of ISO 14971 please contact us for a preliminary discussion.