A Guide to ISO 13485 for Medical Device Manufacturers
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The first step in Gilero’s regulatory approach is understanding the intended use and technology of the customer’s medical device or drug delivery/combination product. Our team will then conduct a regulatory assessment, defining the regulatory pathway for the product. This may include device classification, identification of a predicate device, determination of the primary mode of action (for combination products) or defining other regulatory requirements.
Once the regulatory pathway has been defined, our internal experts will align the outputs of our design and development process to ensure that documentation and testing will support future regulatory submissions. Gilero can prepare and facilitate correspondence with regulatory bodies through activities such as pre-submission meetings to address any open questions. In certain cases, it can be beneficial to receive feedback from regulatory agencies early in the development process to further clarify and confirm our approaches to device testing, human factors engineering, clinical trials, etc.
Gilero can prepare and maintain design history files or device master files, which offer evidence of the evolution of the design and assessment of risk throughout the development process. For combination products, we focus on documentation required for the device and interactions between the drug/device or biologic/device. This, paired with the drug side, offers a comprehensive package for our customers developing combination products.
Once all regulatory documentation is completed, Gilero can file the submission with the applicable regulatory body on behalf of our customer, if requested, and lead correspondences and responses required until the product is cleared or approved for the market.
After regulatory submission, Gilero can provide ongoing regulatory consultation services throughout a product’s life cycle, or as new requirements are published by regulatory agencies.