Applied Technical Services’ technical file remediation services help medical device manufacturers address deficiencies in their device submissions. Manufacturers must comply with their region’s documentation, testing, and safety requirements before marketing products to healthcare providers and consumers. The submission process is meticulous, and regulatory entities may require remediation of flawed documents. Our consultants help clients resolve issues that delay device approval by remediating technical files.
What is a Technical File?
A technical file is a collection of documents that provide key details on a new medical device’s safety, performance, clinical data, design rationale, and potential risks. These files are required for devices to be sold in the US and EU. Manufacturers must include vital information, such as:
- Device classification description- Intended use
- Design drawings and specifications
- Risk management documentation
- Clinical evaluation data
- Performance testing results
- Labeling and instructions for use
- Manufacturing and quality control information
A technical file demonstrates how the subject device complies with region-specific regulations and laws governing medical devices.
What is Technical File Remediation?
Technical file remediation is the process of finding and fixing gaps or inconsistencies in a medical device’s technical file. Our consultants review the device’s design history, risk management, labeling, and performance or clinical data. We ensure the information complies with FDA and EU MDR requirements.
More About Our Technical File Remediation Services
Our services have helped over 200 devices pass the FDA 510(k) submission process. Our team knows the data and attention to detail needed for medical device approval. Approval can already take several months or years, even when things go well and an incomplete technical file can cause long delays or rejection. We help clients avoid setbacks through research and experience-driven strategies. Our reviews ensure clients’ technical files align with FDA and EU MDR expectations.
Contact Us
Call +1 (888) 287-5227 or complete a web form to learn how our technical file remediation services streamline your path to regulatory compliance.
