How to Write an SOP for a Medical Device
There is no shortage of documentation required when developing a medical device. Standard operating procedures (SOPs) are one essential piece of documentation required to get your medical device approved and on the market. Putting together this documentation can be confusing, but when it is done well, this documentation provides clear directives. Writing an SOP that is clear and effective can make the difference between an approval process riddled with issues and a successful device.
The first step in writing an effective SOP for a medical device starts with understanding the purpose of these documents. SOP’s can serve many different purposes, and while they are a required checklist item for regulatory compliance, they are not a reiteration of regulations. Before you begin writing, you should get clear on what you are writing and for whom you are writing it.
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What is an SOP?
Standard operating procedures (SOPs) provide written instructions for completing specific tasks. Ultimately, an SOP provides the basis for quality control activities. These documents address process and safety compliance steps that help keep things uniform during testing, production, and use. These documents are a vital level of protection if problems arise with the use of the device in the future.
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An SOP provides detailed operational information that allows anyone with any experience to replicate a procedure or a process. Companies use these documents to ensure consistency in processes, products, and people. In addition to providing a framework for quality measures, SOP’s can improve efficiency by keeping everyone on task and ensuring that preventative maintenance needs are up to date.
These documents can also serve as training documents for new hires or performance checklists for current employees. But most importantly, when something goes awry, these documents provide a basis for exploring the root cause of the problem. Ultimately, regulatory bodies that provide oversight for medical devices want to see the stringent protocols during device development. They want a solid framework to rely on if there are problems with devices down the road.
When Do You Need an SOP for a Medical Device?
The medical device industry is full of regulatory hurdles. Maintaining compliance with all the governing bodies is paramount during each phase of device development. That means that you’ll be creating SOPs for different purposes. The short answer is that any time there is a process, your company should create an SOP to document that process. Here are some common examples of when an SOP might be solicited for your device: 1) Document Control, 2) Manufacturing Processes, 3) Transporting Devices, 4) Storing Devices, 5) Supplier Management, 6) Reporting Defects or Other Problems, 7) Risk Management, 8) Design Controls, 9) Biocompatibility, 10) Publications, 11) Registrations, 12) Training, 13) Clinical Investigations, 14) Clinical Evaluation, and 15) Post-Market Surveillance.
Imagine yourself caring the “SOP torch” during the creation of SOPs. The Olympic torch heralds the start of the Olympic Games and transmits a message of peace and friendship along its route. You too can send a message that correctly written SOPs can create peace and friendship within your organization.
Each SOP should aim to document how activities are performed. Care should be taken to ensure that the SOP addresses quality assurance and regulatory compliance needs and outlines a process for validating results and calibrating equipment.
Global Strategic Solutions is committed to promoting safety in health care through diligent risk management for device manufacturers. Learn more today.
How to Write an Effective SOP that can Light the Torch in Your Organization
Not all SOPs are created equally. Some contain ambiguous language that can be difficult to understand. Some fundamentally miss key steps. And some are incomplete. So, that begs the question, when writing an SOP, how can you ensure that it is effective?
The most practical approach is to write from the end user’s point of view. While the author of the SOP might be the subject matter expert, those who will rely on this document are anything but experts with the device. That requires the ability to be objective. Follow these suggestions: 1) Write clearly and concisely. 2) Use common language and provide definitions when technical language is required. 3) Stick to a step-by-step format. 4) Use directive language like “identify,” “evaluate,” or “investigate.” 5) Aim for precision, giving exact measurements when possible. 6) Format for easy reading.
A trick that I use in Word is to check the readability statistics. Go to Home, Editor, and Document Statistics. Check both the Flesch-Kincaid Grade Level and Flesch Reading Ease and adjust to your audience.
Use a Clear Format
One thing that can make a significant difference when writing SOPs is sticking to a clear format. Not only will this help each SOP be clear and effective, but it also promotes consistency from one SOP to another. SOPs can be very long, but the list below is a good start.
● Header: Include the title, document number, and version for easy reference.
● Purpose: Write a concise summary of the document’s purpose in one or two sentences.
● Scope: Defines the audience for the SOP.
● References and Documents
● Definitions: Spells out definitions for acronyms and technical language uses therein.
● Roles and Responsibilities: Defines who is responsible for what.
● Procedure: Generally outlined in a step-by-step process.
● Appendices: Flow charts and other visual aids.
● Revision History: A record of changes.
● Approval Signatures: Documentation that appropriate parties have reviewed and signed off on the SOP.
Global Strategic Solutions, LLC has been involved in creating, revising, or editing hundreds of SOPs. If you need help, let’s talk.
Mistakes to Avoid When Creating an SOP
Standard operating procedures are detailed, and that’s why it can get confusing when creating them. The goal is to keep them clear, concise, and on target. You should generally try to avoid including more than what is necessary. Some people try to copy regulatory guidelines word-for-word, making sure that they cover all their bases. In reality, this just bloats the SOP with distracting information and obscures the true purpose of the document. You should also avoid adding too many different roles and responsibilities under one SOP. If things become muddled, consider creating separate documents for each role.
Related: Creation of Sufficient Clinical Evidence
Another common mistake is that company’s overlook version control records. The truth is that things change over time, and it’s imperative to keep an accurate record of those changes for historical purposes.
Final Thoughts on Writing an SOP for a Medical Device
Writing SOPs should be an engrained process for any medical device company. It’s not a one-and-done activity. You’ll likely need to create dozens of these documents to cover every facet of your business as well as every device in your development program. Understanding the purpose of the SOP and how to write clearly and effectively is key to getting the green light during your device approval process. We recommend choosing a standard format and keeping it simple with clear language and easy-to-read formatting. If you need help,
Global Strategic Solutions is your partner in managing medical device risk. Learn more today.
David R Rutledge, Pharm.D., FCCP, FAHA, President & CEO
David.Rutledge@GlobalStrategicSolutions.com, https://globalstrategicsolutions.com/ +1 (630) 846-0350 cell