Defining SOP’s as they pertain to your Medical Device.
If you are developing a regulatory roadmap for your health innovation, you will come across the acronym SOP (Standard Operating Procedure). But what is an SOP and how does it affect your medical device’s journey to market?
By definition, it’s a document that describes the regularly recurring operations relevant to the quality of the investigation. The purpose of an SOP is to ensure operations are carried out correctly. Standard Operating Procedures for medical devices are very detailed instructions that explain how each department or team should complete certain tasks.
We have put together an introduction to SOPs so that your business can gain a good grasp of what exactly they are and how they impact your business.
What is an SOP?
An SOP (Standard Operating Procedure) is a combination of mid-to-high level written directions that document how your company is completing specific tasks to reach certain regulatory and development goals. SOPs are created for procedures that are routine and regular, such as document control, and should also be developed for important tasks that aren’t so regular, like CAPAs (corrective and preventive actions).
SOPs are essential to a medical device companies’ quality management system (QMS). They serve as guidelines to the teams who are carrying out certain tasks, to ensure those tasks are executed properly and in a consistent manner. They address process and safety requirements to ensure the highest quality and effectiveness possible for that product.
So how do you show proof of having quality SOPs in place when the FDA comes knocking at your door? Your team institutes an effective documenting process for all SOPs being carried out. This not only creates evidence for regulatory compliance but also prevents future situations that could warrant an inspection by the FDA. In the event where a problem does arise, your organization’s SOPs will serve as a key factor for corrective action of that problem.
Unsure how to institute an effective SOP documenting process? We can help!
When are SOPs Required for Medical Devices?
Medical device companies must adhere to a lot of requirements to maintain regulatory compliance, and those adherences must be clearly documented. Here are a few areas where SOPs are required:
- Document controls
- Design Controls
- Manufacturing
- Risk management
- CAPAs
- Training
- Clinical evaluations
Within your company, every procedure for your day to day operations should have an SOP. Their purpose is to:
- Manage quality control and assurance processes, ensuring compliance with regulations.
- Document how tasks are to be fulfilled to maintain uniformity and to sustain quality practices.
- Report the measurements taken to validate processes, such as processes for maintaining, calibrating, and using specific equipment.
SOPs Role in Building Quality Processes
SOPs are one of the primary building blocks to creating a solid quality foundation in your business. They help keep your medical device development on a safe and efficient track while demonstrating to FDA that you take your quality processes very seriously.
One cannot have a strong quality program without a set of thorough and detailed SOPs, yet writing these SOPs can be a stressful and challenging effort that many healthcare and life science companies need assistance with. You are not alone if the thought of writing your own detailed SOPs brings a wave of confusion.
Here at Sierra Labs, we often help companies in the regulated space write SOPs that are up to FDA and other regulatory bodies’ standards (not the generic and unspecific ones that can be downloaded from the internet that often fall short of compliance). We can help you design your SOPs and shape your quality program by providing support to your quality teams and functions.
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