PROJECT ON INPUT AND OUTPUT DEVICES ISO
PROJECT ON INPUT AND OUTPUT DEVICES PLUS
PROJECT ON INPUT AND OUTPUT DEVICES SERIES
PROJECT ON INPUT AND OUTPUT DEVICES DOWNLOAD

Risk management is a critical part of regulatory compliance and has a direct link to design control. The finished design output documentation is the basis for your device master record (DMR). Work instructions, installation and servicing proceduresДЄgain, all of these outputs must be verified against applicable design inputs.Quality assurance specifications, procedures, and acceptance criteria.Manufacturing and purchasing procedures.Component, material, production, and process specifications.Of course, this begs the question: What constitutes design output? Here are some examples:

The outputs also provide needed important information for purchasing, production, and servicing. All of this must be documented, reviewed, and approved before the design is released. Design output requirements are intended to apply to all stages of the design process, and to characterize important aspects of the design.Дesign output documents must define the critical outputs (specifications, properties) and reference your acceptance criteria. It is also essential to know whether those design and development inputs result in the right outputs вЂ“ namely, whether the design you created is safe and functions as planned. Medical device design outputsДesign control is not just about controlling the design inputs. For complex designs, it is not uncommon for this design input stage to consume as much as 30% of the total project time. Also, while your developers will play a key role in developing inputs, you should also get input from people closest to the customer, such as people in Marketing, Tech Support, and Sales. Are they lay consumers? Doctors? Medical technicians? This is vital, because all design verifications and validations are matched to customer needs and related technical requirements. They ultimately bear responsibility for translating needs into a set of requirements that can be validated prior to implementation.ДЄs you define inputs, it is important that you properly identify the customers using your device. Your product developers play a key role (but not the only one) in developing the design input requirements, regardless of who developed the initial product concept. Basically, design inputs should specify what the design is intended to do but they should avoid specific design solutions. Other requirements essential for design and developmentДЄll of these inputs must be documented, reviewed, and approved for adequacy, and you need to make sure that the requirements are complete, clear, and donвЂ™t conflict with one another.

Information derived from similar designs.Functional, performance, and safety requirements for intended use.Procedure for design requirements (intended use, patient and user needs).

Essentially, the key requirements include a need to determine:

PROJECT ON INPUT AND OUTPUT DEVICES ISO

Section 7.3.3 of ISO 13485:2016 and section 820.30 of the FDA QSR talk about design inputs. Why? The requirements that make up the design inputs establish a basis for performing subsequent design tasks and validating the design. Of all the design control activities, developing a solid foundation of requirements is the most important. Now letвЂ™s talk about the specific design inputs that need to be defined and tracked.

PROJECT ON INPUT AND OUTPUT DEVICES DOWNLOAD

Download it here.Д®arlier (in a previous post) we addressed the importance and necessity of design control planning.

PROJECT ON INPUT AND OUTPUT DEVICES PLUS

WeвЂ™ve also combined all three posts into one easy-to-read PDF, plus added some extras. We cover the basics of design control in our first post and look at DHR, DHF and DMR in our final post.

PROJECT ON INPUT AND OUTPUT DEVICES SERIES

This is the second post in a 3-part blog series on medical device design control.

Project on input and output devices