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The design validation report is the conclusion of the study that has been made on the customer requirements. The design validation plan has identified the need for the validation and the protocol identified the methodology that should be followed.
A design verification report is required to interprets the results of the methodology stated in the design verification protocol and it states whether the acceptance criteria have been met or not.
A preview of the Design Verification Protocol is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The DHF checklist will help your 510K application to the US. It provides a succinct table of what your DHF should have and ensure your contents are adequate.
This document illustrates the relationship between the economic operators and addresses the responsibilities of each one.
A preview of the Economic Operators Gap Assessment is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
Failure Mode & Effects Analysis (FMEA) has become a critical Six Sigma tool among businesses that are increasingly intent upon bringing more precision to solving their risk management challenges.
The Gap Analysis Template can be used as a guide to assist in site inspections/audits for Medical Device manufacture.
A 3-page preview of the Gap Analysis Report Template is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This document will help you understand whether your products falls under the definition of systems and procedure packs as per the 1993 Medical Device Directive (MDD) and the new 2017 Medical Device Regulation (MDR), how to classify your product and which actions to take to get on track for compliance with new MDR requirements.
A preview of the Guidance for EU MDR – Systems and Procedure Packs is available here:
You may purchase the full document in convenient Microsoft Word format including instructions for use below.
The new European medical device regulation, EU MDR 2017/745 has seen the introduction of a new subclass of Class I devices covering reusable surgical devices and the reprocessing of single-use devices for sale on the European market.
This guidance document aims at helping manufacturers determine the classification of their device; provide a reference to the broader MDR; understand the requirements of their device regarding conformity and the documentation supplied with the device.
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You may purchase the full document in convenient Microsoft Word format including instructions for use below.
This guidance document is aimed at helping manufacturers of medical device products that are designed to be used in combination with substances that are considered pharmaceutical drugs or medicinal products (Drug-Device combination prodcuts), understand whether their product(s) will be regulated as a drug or regulated as a device, the classification and relevant regulations that apply to their products(s) and the implications of the new EU Medical Device Regulation 2017/745 on existing and new drug-device combination products.
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You may purchase the full document in convenient Microsoft Word format including instructions for use below.