Quality

Medical Device SOPs (Standard Operating Procedures)

The most critical documents you use in medical device development are standard operation procedures (SOPs). MasterControl Quality Excellence ensures you use the right process and template to create your SOPs, so they remain accurate, current, and compliant.

Medical device development is complicated and highly regulated. Therefore, your SOPs must be written with enough operational detail that anyone can follow the procedures to complete a task. You can achieve this by creating a standardised framework for your SOPs. MasterControl’s Basic Procedure SOP Template will help you set up the right kind of framework.

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Basic Procedure SOP Template (Word Document)

FAQs about Medical Device SOPs

How can you develop an effective SOP for medical devices?

Use an SOP template to help avoid missing key information or steps — or making the content too confusing for your audience. It’s also important to use common language, define all technical terms, and use a step-by-step format for procedures.

Are there any regulatory requirements for medical device SOPs?

21 CFR Part 820.70 states that manufacturers must develop, conduct, control, and monitor production processes to ensure a device conforms to its specifications. Process controls need to include documented instructions, standard operation procedures (SOPs), and methods that define and control the manner of production.

How often should medical device SOPs be reviewed and updated?

It’s important to ensure SOPs remain up to date and compliant with current regulatory standards. Therefore, companies need to review and update the documents once a year or at least every two years.

How do you train employees on medical device SOPs?

When employees join the company or move to a different role, they need to be trained on the relevant SOPs by attending courses or completing self-based training. Updating training is also important. Many companies send out re-training notices on their SOPs annually to ensure employee comprehension and compliance with regulatory standards.

Free Resources on SOP Development for your Medical Devices

Select all the SOP development resources you’re interested in downloading.

Industry Brief: 6 Common Myths About Adopting a Manufacturing Execution System (MES)
White Paper: Modern Manufacturing: The Investment in Digitization Costs Less than Falling Behind
Research Report: The State of Digital Maturity in Pharma and MedTech Manufacturing
Ultimate Guide: The Ultimate Guide to Digitizing Medtech Manufacturing
Trend Brief: 2024 Medical Device Industry Trends

Best Practices for Developing Medical Device SOPs.

Using a consistent format across all your SOPs helps ensure that your intended audience can quickly and easily read and understand the instructional material.

Eliminate the potential for errors.

Most production issues are caused by human error. Poorly written medical device SOPs are one of the most common causes of deficiencies and observations cited in Form 483s or warning letters from regulatory agencies. Use a concise and well-organised SOP template to help ensure errors don’t occur due to employees misunderstanding the work instructions.
Define all terms.

Sometimes terminology is necessary. Even if a term seems like it’s commonly understood in your industry, your SOP should define and explain it.
Every SOP should have an accountable stakeholder.

All SOPs need to be reviewed and updated on a regular basis. The SOP’s owner is responsible for making sure it’s up to date and aligns with the current processes.
Include results.

When creating instructional materials, it’s helpful to include what will come out of the process or what the result will look like. This is important to meet compliance and ensure everyone is following the same measures to get the same results.
Document everything.

Some steps in a procedure might seem like common sense or the staff is skilled enough with a process to complete a step without being instructed. Regulatory guidelines state that every step of a process must be included in the SOP.

Need more information about creating standard operation procedures (SOPs) for Medical Device Manufacturing?

MasterControl experts are here to answer your questions. Our goal is to help you succeed in your manufacturing operations. Contact us to learn what MasterControl can do for you.

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Master SOP development with MasterControl Quality Excellence

SOP Best Practices

Creating a standard framework for your SOPs helps foster operational efficiency, mitigate risks, and ensure compliance.

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Improve Compliance of SOPs

Creating compliant medical device SOPs is easier with the proper structure and tools. See how much more control you have of SOPs using an SOP software solution.

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Audit-Ready SOPs

Proper SOP management is essential to achieving regulatory compliance. See how quality management software helps you comply with regulations.

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Find the Ideal SOP Solution

Find the ideal SOP development processes and SOP software. Discuss solutions with a personal representative.

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SOP Compliance Simplified

Improve your manufacturing performance with effective SOPs.

A standardised framework for your standard operation procedures (SOPs) is key to developing effective, audit-ready documents. An SOP serves as a documented method for manufacturing processes within your company, including step-by-step instructions and best practices to maintain efficiency and compliance.

The right SOP structure and template help ensure operational efficiency. Find out how MasterControl helps you excel at:

Developing accurate, clear, and consistent SOP documents.
Effectively tracing and managing SOPs, ensuring only up-to-date SOPs are in use.
Making sure all your SOPs are reviewed, updated, and approved on a regular schedule.

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Medical Device SOPs (Standard Operating Procedures)

FAQs about Medical Device SOPs

How can you develop an effective SOP for medical devices?

Are there any regulatory requirements for medical device SOPs?

How often should medical device SOPs be reviewed and updated?

How do you train employees on medical device SOPs?

Free Resources on SOP Development for your Medical Devices

Best Practices for Developing Medical Device SOPs.

Eliminate the potential for errors.

Define all terms.

Every SOP should have an accountable stakeholder.

Include results.

Document everything.

Need more information about creating standard operation procedures (SOPs) for Medical Device Manufacturing?