MDR Gap Analysis

Hi How are you? I can help you with your project. I have 12 years experience in the medical device industry. My last role was as a quality systems engineer, in a company that was seeking FDA approval for a new device. In preparation for this, all site processes and systems were reviewed for compliance, identifying any deficiencies present and implementation of appropriate corrective actions. Additionally, I am very knowledgeable on the requirements of the following ISO standards: - 13485:2016 - 9001:2015 - 14971:2007 - 11135:2014 - 14644 (1&2):2015 - 14698 (1&2):2003 I would be extremely interested in working on this project, so please contact me to discuss further. Thanks Stephanie

Technical writing is the practice of documenting processes, such as software manuals or instructional materials. Traditionally, it was limited to user manuals of some sort. Frankly, this definition has become outdated. Technology moves quickly, and lexicographers are often left playing catch up. Today technical writing encompasses all documentation of complex technical processes. It includes reports, executive summary statements, briefs. Any time technical information is conveyed in writing at work, it is, by definition, technical writing. This can include high-tech manufacturing, engineering, biotech, energy, aerospace, finance, IT, and global supply chain. The format is no longer bound to lengthy user manuals. Technical information must be distilled and presented unambiguously. This can come in the form of technical reports, emails, policy, briefs, and press releases. As a professional freelance writer, I'm very much experienced in this field of Technical writings. Regards, Battiston

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