Parker Quality & Compliance is a Southeast US company that prepares practical quality and regulatory templates for medical device manufacturers and related organizations.
The templates are built by a medical device quality manager with over ten years of hands-on QMS experience, including FDA and notified body audits. The templates in this shop are original, generic documents designed as starting points for common processes — including complaint handling, CAPA, post-market surveillance, reportability, internal audit, and related SOPs. They are informed by publicly available requirements and widely used practices associated with frameworks such as ISO 13485, 21 CFR 820 / QMSR, 21 CFR 803, and EU MDR. They are not copies of any copyrighted standard, and they are not endorsed by any regulator or standards body.
Every organization, product, and quality system is different. These documents are meant to be edited, reviewed, and approved under your own procedures. They are not a substitute for qualified quality, regulatory, or legal advice, and they do not certify or guarantee compliance.
All listings are instant digital downloads for single-company internal use. Please read the listing description, licence terms, and disclaimer before you purchase. If a file does not download or is not as described, message the shop and I will make it right.
Parker Quality & Compliance also offers consulting for medical device quality teams. Our Complaint File Mock Inspection samples your closed complaint files and reportability decisions the way an inspector would, and ends with an observation list, a prioritized fix list and a readout. Details are at pqcregwatch.com.
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Cancellations: not accepted
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Frequently asked questions
What will I receive?
An instant digital download — typically an editable document (for example, Microsoft Word) and/or a PDF, sometimes packed in a ZIP file. Each listing states the exact formats and what is included (SOP, forms, logs, or a bundle). Nothing is shipped.
How do I download my files?
After payment confirms, Etsy emails a link and the files appear in your Etsy account under Purchases → Download Files. Use a computer or mobile browser. The Etsy app cannot currently download digital files. In most cases you can download the files more than once from Purchases, unless the transaction is canceled or removed.
What software do I need?
Word or PDF files open in Microsoft Word, Google Docs (with possible layout differences), Adobe Acrobat or another PDF reader, or similar software. Listings that include spreadsheets will say so. You are responsible for having software that can open the stated formats.
Can I edit the templates?
Yes. These are generic starting points. Edit them to match your company’s process, organization, product, and quality management system. They are not ready to use “as-is” as your controlled procedures.
Do these templates make my company compliant with ISO 13485, 21 CFR 820 / QMSR, 21 CFR 803, or EU MDR?
No. They are educational and operational starting points informed by publicly available regulatory requirements and widely used quality-system practices. They are not certified, approved, or endorsed by any regulator or standards body. You are responsible for reviewing, adapting, approving, and implementing them under your own quality system. See the “not regulatory advice” disclaimer in every listing.
What is the licence?
You receive a licence for single-company internal use only:
- One company (the buyer’s organization) may use, copy, and adapt the files for its own internal quality system
- You may not resell, sublicense, share, or distribute the files (or derivatives) to other companies, clients, or the public
- You may not list these files, or templates derived from them, for sale on Etsy or any other marketplace
- Consultants may use a purchased template only inside the purchasing organization, not as a deliverable or reusable kit for multiple clients, unless a separate written licence is arranged
Can you customize a template for my company?
This shop sells ready-made instant downloads, not custom writing or consulting. If you need something that is not in the listing, message the shop and I will tell you whether I can help and how.
Do you offer refunds?
Digital downloads are not returnable or cancelable once delivered. I will replace or refund an order if the file is not delivered, will not open, or is not as described. See the digital download policy.
I can’t open the file or the download failed. What should I do?
Try a different browser, disable blockers, and download again from Purchases. If it still fails, message me with your order number and a brief description of the error.