IEC 62304 is not mandatory, however, it’s recommended that organizations who develop medical device software follow its requirements.
What IEC 62304?
IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety. It applies to the development and maintenance of medical device software when: The software is itself a medical device.
Does FDA require 62304?
Because it has been harmonized with the Medical Device Directive in the EU and recognized as a Consensus Standard by the FDA in the US, IEC 62304 can be used as a benchmark to comply with regulatory requirements in both markets.
What is ISO 13485?
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
What is the latest version of IEC 62304?
The second version of IEC 62304 is still in draft. It has been in this state for five years, since the publication of the amendment 1. We already had a draft version in 2019. A new draft version is, again, in public review (or has been in public review in your country) under the name IEC CDV 62304:2021.
What are the applicable life cycle process for IEC 62304?
Software Development Process
- development planning.
- requirements analysis.
- architectural design.
- detailed design.
- unit implementation and verification.
- integration and integration testing.
- system testing.
How many Specialities has the FDA grouped medical devices into?
FDA has classified and described over 1,700 distinct types of devices and organized them in the CFR into 16 medical specialty “panels” such as Cardiovascular devices or Ear, Nose, and Throat devices.
What is medical device single audit program?
The Medical Device Single Audit Program (MDSAP) is a program that allows the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
How are medical devices classified in general?
Medical device classification based on risk
Class Is (sterile device) = Low risk. Class IIa = Medium risk. Class IIb = Medium to high risk. Class III = High risk.
Who can certify ISO 13485?
It is NOT a personal standard – a person cannot get certified to ISO 13485. Instead, an organization or company becomes certified. An individual, however, CAN become an ISO 13485 Certified Lead Auditor after a 5-day training course. This then allows them to audit other companies.
What is the difference between ISO 9001 and 13485?
ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices.
Is ISO 13485 certification mandatory?
Like other ISO management system standards, certification to ISO 13485 is not a requirement of the standard, and organizations can reap many benefits from implementing the standard without undergoing the certification process.
What is the current version of ISO 14971?
There are two versions of ISO 14971 that are currently available. The first is the international version: ISO 14971:2007. The second is the European normative version: EN ISO 14971:2012. There is also a new draft being created by the TC210 committee for release in 2019.
What is meant by SDLC?
The Software Development Life Cycle (SDLC) is a structured process that enables the production of high-quality, low-cost software, in the shortest possible production time. The goal of the SDLC is to produce superior software that meets and exceeds all customer expectations and demands.
Is a toothbrush a medical device?
In this example, a manual toothbrush is a class 1 medical device. A manual toothbrush is 510(k) exempt, meaning it does not require premarket notification or approval.
What is 510k certification?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&
What is the difference between a Class 1 and Class 2 medical device?
Class I devices present minimal harm to the patient and are generally simple in design. Class II devices, while typically non-invasive, pose a higher degree of risk and must offer a higher level of assurance that it will not cause injury or harm.
What is the difference between ISO 13485 and Mdsap?
ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other. MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP.
Does Australia require a CE mark for medical devices?
The five founding members are: 1) the USA, requiring a 510(k) or PMA
2) Canada, requiring a Medical Device License
3) Europe, requiring CE Marking
4) Australia, requiring Australian Register of Therapeutic Goods (ARTG)
and 5) Japan, requiring Japanese Pharmaceutical Affairs Law (JPAL) certification or approval.
Is Mdsap mandatory for Australia?
So, what is MDSAP? The MDSAP will become mandatory for all manufacturers who wish to sell their medical device products to other global markets. Later, the United States, Brazil, Australia and Japan will follow the MDSAP program.
How do I get FDA approval for medical devices?
To get FDA approval for your medical device, you’ll need to go through the following five steps.
- Know Your Device’s Classification. Medical devices fall into three classes:
- Develop a Prototype.
- Submit Your Applications (If Applicable)
- Wait for FDA Review and Approval.
- Maintain FDA Compliance.
What is a Class 3 medical device?
Class III – These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.
What is a Level 2 medical device?
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits.