100% satisfaction guarantee Immediately available after payment Both online and in PDF No strings attached
logo-home
Previously searched by you
Previously searched by you
logo
ISO 14971 - Key Terms and definitions Questions & Answers CA$18.25
Add to cart
Quickly navigate to
Preview
  2.  
  3. Wrt
  4.  
  5. Wrt

Exam (elaborations)

ISO 14971 - Key Terms and definitions Questions & Answers
 0 purchase
  • Course
  • Wrt
  • Institution
  • Wrt

ISO 14971 - Key Terms and definitions Questions & Answers Scope of term 'RISK' wrt ISO 14971 When the term "risk" is used, the application of the term within the scope of this International Standard pertains to safety or performance requirements of the medical device or meeting applicable regul...

[Show more]

Preview 1 out of 2  pages

Document information

  • October 20, 2024
  • 2
  • 2024/2025
  • Exam (elaborations)
  • Unknown

Subjects

  • iso 14971 key terms and definitions questions
  • scope of term risk wrt iso 14971 when the term
  • risk combination of the probability of occurrence

Written for

  • Wrt
  • Wrt

Seller

avatar-seller
Pogba119

Reviews received

Content preview

ISO 14971 - Key Terms and definitions
Questions & Answers
Scope of term 'RISK' wrt ISO 14971 - answer When the term "risk" is used, the
application of the term within the scope of this International
Standard pertains to safety or performance requirements of the medical device or
meeting
applicable regulatory requirements.

risk - answer combination of the probability of occurrence of harm and the severity of
that harm

harm - answer injury or damage to the health
of people, or damage to property or the
environment

hazard - answer potential source of harm

hazardous situation - answer circumstance in which people, property,
or the environment are exposed to one
or more hazard(s)

life-cycle - answer all phases in the life of a medical device,
from the initial conception to final
decommissioning and disposal

objective evidence - answer data supporting the existence or verity
of something

post-production - answer part of the life-cycle of the product after
the design has been completed and the
medical device has been manufactured

residual risk - answer risk remaining after risk control
measures have been taken

risk analysis - answer systematic use of available information
to identify hazards and to estimate the
risk

risk assessment - answer overall process comprising a risk
analysis and a risk evaluation

The benefits of buying summaries with Stuvia:

Guaranteed quality through customer reviews

Guaranteed quality through customer reviews

Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.

Quick and easy check-out

Quick and easy check-out

You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.

Focus on what matters

Focus on what matters

Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!

Frequently asked questions

What do I get when I buy this document?

You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.

Satisfaction guarantee: how does it work?

Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.

Who am I buying these notes from?

Stuvia is a marketplace, so you are not buying this document from us, but from seller Pogba119. Stuvia facilitates payment to the seller.

Will I be stuck with a subscription?

No, you only buy these notes for CA$18.25. You're not tied to anything after your purchase.

Can Stuvia be trusted?

4.6 stars on Google & Trustpilot (+1000 reviews)

68175 documents were sold in the last 30 days

Founded in 2010, the go-to place to buy study notes for 15 years now

Start selling
CA$18.25
  • (0)
Add to cart
Added