It is much easier to illustrate and define a product when describing both the included and the excluded parts and aspects. 3. A well-crafted specification document can become a one-stop reference for personnel involved in the design and development process. Over the past few years, our team has worked with dozens of systems engineers and business analysts working on ambitious medical device projects to create the ultimate list of tips on how to write product requirements documents that are a dream to author and use. Here is a simple way to distinguish between the two – a product-brief should focus on the long-term aspects of the product – the ones that last forever. (e.g. The requirement statements should be written in a consistent voice that reflects the active nature of the requirement. Make sure to pay the needed attention and time in understanding and properly defining the product’s soft-attributes as well. Most product-briefs tend to focus on the product’s hard-attributes. by (evidence/test). Sticking with consistent terminology makes it easier to search through requirements quickly and minimizes the risk of incorrect interpretation. The product-brief should focus on the expected goals (what). Here is a list of eleven guidelines and insights about how to manage your product-brief. The product-brief writing is perhaps the activity with the highest ROI, as it costs very little … Of course, this template should be adjusted as-needed. 5. – This reads as non-negotiable, it MUST interface, "The device should interface with common accessories." This is clear and concise. Perform cross-functional design reviews to assess your requirements before implementation, 9. Introducing Greenlight Guru Visualize: Interact with your quality system in a new way by building, seeing, and achieving closed-loop traceability. Product-brief should also include the excluded I prefer to use a Product-Brief Checklist just to remind me the main titles (it never covers the whole points) that I have to consider. The device must be able to withstand a consistent flow rate of 5L/min for 30 minutes. A well-crafted specification document can become a one-stop reference for personnel involved in the design and development process. The product-brief is also a professional agreement about the product’s definition between all project’s members – managers, marketing people, engineers, designers, suppliers, clients and so forth. Software Design Specification Example. Take the example of a website when you receive an order to design a website. One way to make sure that your requirements are specific is to eliminate the use of inherently weak words such as user-friendly, reliable, capable, etc. It is the design work’s responsibility to find the best solutions to achieve these goals (how). A change control system should be in place to capture these changes. 2-for-1: Free eBook + Checklist for Writing Product Requirements, 10 Essentials for Writing a Clear Product Requirements Document [Guide+Checklist]. He approaches the document slightly differently, but shares a similar sentiment. The Ultimate Guide To Design Controls For Medical Device Companies. Is this talking about the user-interface, ergonomics, or other features that the user interacts with? Use imperatives such as “shall” or “must” properly and consistently, 4. “The device must be user-friendly” – This is a weak requirement that leaves many questions unanswered. When writing a medical device essential requirements checklist, it is important to keep in mind that you must be able to demonstrate how the requirement is met. Writing and managing the product-brief is a crucial part of a design process. Never run a product design project without a significant product-brief, even if it seems as if “it’s all clear”. Pingback: In the Beginning, There Was…? By committing to solve the complexity issues in engineering that hinder innovation, QRA’s tools help engineers build tomorrow’s safe, secure, and incredibly powerful products. Broad requirements are weak and difficult to verify. Following these tips can help ensure you are incorporating risk assessment, meeting design controls requirements, and creating a document that will easily stand-up to a regulatory inspection. The product-brief is a plan and a compass – it defines the product’s goals and attributes, and shows you where to go. The product-brief has a great impact on the product’s quality and character, and the project’s efficiency. The product-brief writing is perhaps the activity with the highest ROI, as it costs very little and brings great value, as well as saves a lot of time and money while preventing wrong directions and unexpected outcomes. 2.6.4 Final design specification (FDS) An FDS must include all necessary drawings, dimensions, environmental factors, ergonomic factors, aesthetic factors, costs, requirements, quality, safety documentation, and disposal methods. Who are the users? Click here to download the free eBook PDF of this guide AND printable checklist. Define “what” not “how” You can write an all-important feature that must be taken care of in addition to the basic specification in the important feature section. Anyone that works in the Quality or Regulatory side of medical device is well-versed in reading standards and regulatory requirements like ISO 13485 closely for shall and should statements. Even though it holds incredible power, good product copy can be hard to write. That being said, you should not change existing specifications unless a major design change is encountered. The next steps you are required to follow is to make … The design review requirements outlined in ISO 13485 require that personnel involved in the design stage attend the design review. You never know everything in advance; new information, insights, and decisions are usually raised during the project and affect the product-brief. The latest revision of ISO 13485 expanded risk assessment to the entire quality system and the new MDR 2017/745 regulations also put more emphasis on risk assessment. Over the past few years, our team has worked with dozens of systems engineers and business analysts working on ambitious medical device projects to create the ultimate list of tips on how to write product requirements documents that are a dream to … – This reads an optional or nice to have feature. Keep it short and simple Requirements should be written so that they contain a clearly measurable objective. This also includes consistently referring to acronyms or abbreviations. The (component) must (verb) (challenge criteria/requirement) as measured by (evidence/test). If you cannot quickly come up with an objective way to show that the requirement has been met, it probably needs to be rewritten. 6. The product-brief is a plan and a compass – it defines the product’s goals and attributes, and shows you where to go. Its intended audience is the project manager, project team, … It’s the product design manager’s responsibility to manage the brief, while keeping all projects’ members involved. This may not mean changing your requirements document for the current version of your device, but it may mean creating a new, draft medical device requirements specification that reflects this new information. William works as a product manager for a payment service provider. Can a requirement be written to mitigate that risk through design? Ultimate Guide to Comparing QMS Solutions, accelerate the requirements engineering phase. Let's look at an example of how to effectively write a product specification document. The PDS is a living document, that is, it will get larger as more about the design is known. This article was originally published on the QRA Team Blog and can be viewed by clicking here. This suggests that this flow rate is an upper limit test and only needs to happen once. Sifting through medical device safety and performance requirements to create medical device requirements specifications can be an exercise of patience, but with the right preparation and approach, it can be more than just another required piece of paperwork. This will make your team to pay special attention to those features. The product-brief is written at the beginning of the project, yet it is necessary to keep updating it all project long. Will you list the requirement under a section for each regulator or will you lump all regulatory requirements into one section to avoid duplication? It is very easy to mix product-brief and project-management, as they are different sides of the same coin. The soft-attributes are more elusive and complicated to define, but not less important. QRA Corp, an emerging developer of systems and requirements engineering technology based in Halifax, NS - is accelerating the design process across industries tackling the most complex, mission and safety critical systems. The brief (when it’s up-to-date) is the best reference for the product’s testing stage. The key takeaway from this tip sheet should be that a little bit of planning and consistency in the beginning of the requirements process will save time and effort in the longer term. The component must contain no more than 5mcg of harmful leachables as measured by a negative result from cytotoxicity testing. 2. Please complete this form and click the button below to gain instant access. We distilled the insights from our research into this one guide + checklist that we hope will help accelerate the requirements engineering phase of your medical device projects. A product-brief is one of the most important elements in a product design project. You can try using my Product-Brief Checklist, With my PLM twisted mind, I tried to replace Product by PLM Vision. Of course it is better to have all the answers in the product-brief, but it is absolutely normal to have open questions as part of the brief at the beginning of the project. This step is not mandatory for all technical specifications. The product-brief is a map. Moreover, agreement on requirements engineering best practices can be a fierce debate. Define requirements in measurable terms, 3. As the project advances through development it is likely that new requirements will be added and existing requirements will be improved upon. Requirements for regulatory agencies often overlap completely or significantly. – Texas Applied Arts(), Welcome to Product Design Management Blog, In the Beginning, There Was…? A smart way to do this is to create an SRS template that you can use as a starting point for every project. Your medical device requirements specifications should be able to stand-alone without supplementary information to explain what “user-friendly” or other broad terms mean. 10. Therefore, we distilled the insights from our research into this one guide + checklist that we hope will help accelerate the requirements engineering phase of your medical device projects. Your requirements document should not require a close reading to determine intent. This specification is the culmination of all the design work that has led to the concept and the detailed design work that has converted the concept into a practical … This is better, but still sounds like an upper limit that the device won’t necessarily hit. This is why there is no such thing as “general product-brief template”. Don’t use (closed) brief templates Every unit of the device must withstand the flow rate. The product-brief is an agreement Don’t mix product-brief and project-management Every product has it own unique environment and requirements. 9. 7. You can write your software requirement specification in Microsoft Word. A typical product-brief should be between 1 to 3 pages long. Looking for a design control solution to help you bring safer medical devices to market faster with less risk? This may later be used to develop a new version of the device or an alternative device to meet customer needs. Acronyms are only useful when they are standardized and understood by all document users. Documenting clear reasons for the requirement change can be helpful later in the development process and can potentially reduce iterations in the development process. It can be especially mind-numbing when you have a long list of items on your product page to work through. Instead, this requirement should be broken down into a series of small, objective requirements. We’ve broken it down into 8 easy-to-follow rules about product description writing that will help you create product copy that sells. Here, I’ll layout the example structure of a proper design document. The Product Design Specification document documents and tracks the necessary information required to effectively define architecture and system design in order to give the development team guidance on architecture of the system to be developed. Writing a PDS Start writing your PDS early in the design process, typically as soon as you have established engineering requirements and done sufficient research. And surprisingly there is much in common. 1. A design project without a brief is like an outdoor trip without a map. is there any samples of product briefs for laptops? Writing an SRS in Microsoft Word vs. Requirement Software. It is important to decide on a strategy for addressing this issue early on when developing requirements. FREE eBOOK + CHECKLIST PDF: Click here to download the free eBook PDF of this guide AND printable checklist. “The part will be made of aluminum” vs. “The part should be lightweight, resist to high temperature, and cost less than $3.00″). Since the requirement document will be covering overall requirements there should be representatives present from all potentially affected departments. Assessing risk continues to be a focus for regulatory agencies. In such cases, you should add notes to the brief about the actions and timetable needed to answer these questions. 11. However, even with a template, writing an SRS this way can be a painstaking process. Defining “how” in the brief might narrow the designer’s options and curtain other solutions. The (component) must (verb) (challenge criteria/requirement) as (measured/verified/indicated/etc.) Maintain an audit trail of requirements improvements for your ISO 13485 Compliant Quality Management System (QMS), [Bonus] Simple Med Device Requirement formula. Whereas the project-management aspects should focus on the short terms aspects – the ones connected to the R&D process, such as to-dos, responsibilities, milestones, budget and so forth. This might save some misunderstanding and mistakes. Getting input from a cross-functional team can minimize hiccups down the line when requirements are being reviewed by areas that may not have seen the requirements document before. 4. Normally, it’s much easier to define and describe a solution rather than a goal. A person unfamiliar with the product or process should be able to come in and verify requirements are met through a review of documentation. Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →. For another example, see Joel Spolsky’s sample specification, based on this write-up. The product-brief is under the design manager responsibility Enforce consistency of terminology and prohibit industry or company jargon, 6. Requirements are living documents for a product that needs to actively meet the general safety and performance requirements continuously. It is much faster and safer to reach your destination when you have a map with a planned route. Avoid duplicate or contradictory requirements, 8. Subscribe to our blog to receive updates. 8. FREE eBOOK + CHECKLIST PDF: Click here to download the free eBook PDF of this guide AND printable checklist. "The device must interface with common accessories." An audit trail should be maintained for all changes to requirements to ensure that the methods and reason for the changes are available for regulatory inspection. The Beginner's Guide to Design Verification and Design Validation for Medical Devices, Complete Guide to Bringing a Medical Device to Market, Understanding the 5 Phases of Medical Device Development, The Art of Defining Design Inputs And Design Outputs, Top 50 Medical Device Product Design and Development Companies, COVID-19 Impact on Medical Device Industry: How to Navigate the Chaos and Support Public Health, 15 Steps to Getting Approval for IEC 60601-1. Further, regulatory requirements and functional or material requirements may overlap as well. As new information about the device is acquired through clinical trials, post-market clinical follow-up, through user experiences, and other pathways, the requirements will need to change. Remember, if it isn’t documented then it didn’t happen! It is possible to make a requirements document that is a helpful, easy to use tool. Remember, the PDS represents what you … A product-brief is one of the most important elements in a product design project. Working on risk assessment in conjunction with requirements is one way of mitigating risk before it getting further down the development pipeline. Depending on the structure of your template it may be easier to list the requirement as both a functional and a regulatory requirement or list all applicable regulations as a source of the requirement. Product-brief can (and should) include questions Your device requirements are subject to change. It has become clear to us that the most devastating project errors and delays begin in the requirements authoring stage. How is “user-friendly” defined? Is there a process that is user-dependent and high-risk? Avoid complicated and long text with too much background details. If there are certain capabilities, features, or any others “naturally expected” aspects, it should be defined as not being part of the product. Once the device hits the market the requirements work is not done, especially as regulatory bodies put increasing scrutiny on clinical follow-up and risk assessment. A few working hours on a good brief writing at the beginning of the project can save you a great deal of time and money. The product-brief has a great impact on the product’s quality and character, and the project’s efficiency. Almost there! It is important to keep your brief (and all project members) up-to-date. Your medical device requirements specification needs to be easily understood by all personnel that may work with it. The software must sync to the server every 15 minutes as recorded by backup records. The Product Design Specification document is created during the Planning Phase of the project. The product-brief is a live document – Texas Applied Arts. Templates are good for cases when you have all the “questions” ready in advance, which is not the case of a new product development. These words are vague and do not tell the user what is being measured (see Tip #2). It may be helpful to include a definitions or glossary section to the requirements document if conflicting terminology is a consistent concern or the requirements document will be used by personnel that may be downstream in the process and use different terminology. The requirements document should be reviewed within your Design Controls process and the review documented accordingly. The device must withstand a consistent flow rate of 5L/min for 30 minutes. The device must be tested at a consistent flow rate of 5L/min for 30 minutes. The product-brief should define the product in a simple and short way. 2. All should be involved in writing and approving the brief, and of course, acting according to it. Design History File (DHF) vs. Device Master Record (DMR) vs. Device History Record (DHR): What's the Difference? Product-brief should include the product’s hard- and soft-attributes