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Author: Carrie Hetrick | Date: February 14, 2022
As you begin the process of designing, developing, and manufacturing your medical device, there are many things you must consider in the early stages to ensure your device can ultimately be approved by the relevant regulatory body, make it to market, and improve the health and healthcare of patients all over the world. One of these important elements is the eventual, but necessary, compliance with good laboratory practice (GLP) guidelines. While they are most relevant to the post-development phase of your product lifecycle, there are steps you can take in the design and development stages to position your product for success.
Good Laboratory Practice (GLP) is a set of guidelines to ensure the quality of nonclinical laboratory studies for planning, performing, and reporting nonclinical safety. Nonclinical study reports are essential information needed to produce high-quality integrated documentation. Nonclinical study reports present the results of studies individually and support a medical product’s development and registration. Nonclinical report formats may vary. These nonclinical studies include things like biocompatibility, sterilization, and animal testing for medical devices. While GLP is not explicitly outlined in regulation, it is a critical element to include when considering how to prepare for an FDA inspection and approval with the U.S. Food and Drug Administration, as well as other regulatory bodies worldwide. GLP guidelines are outlined in21CFR58 under FDA regulation and in the Organization for Economic Co-operation and Development in the European Union.
Before and during your post-development phase, there are steps you can take to make sure you are poised for success in incorporating GLP guidelines into your submission package to regulatory bodies, including:
Understanding standards and guidelines, including GLP guidelines, and submitting a medical device for regulatory clearance or approval can be an overwhelming and confusing process with numerous interconnected aspects. At Sterling, we are regulatory compliance experts, and we can help relieve the stress of the process for you – from medical device prototype development to achieving your regulatory goals. Please contact us today.
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