Bringing Quality Solutions into the 21st Century

We are a team of Quality Professionals utilizing technology to provide a modernized solution for determining compliance with regulatory requirements.

What does our Digitial Auditor Application offer?

It is the most obvious step in the evolution of auditing, providing both trained and un-trained auditors with a way to perform audits quickly and effectively through a modernized process. The following list outlines a few of the benefits of utilizing our Digital Auditor Application;

  • Always have an up-to-date checklist of the regulations
  • Able to record notes, findings, etc. digitally and then transfer the information to a report with the press of a button
  • Reducing the time from the start of the Audit process to the closing meeting, and thereby reducing cost

Watch It In Action

20

Clients

30

Projects

100

Hours Of Support

2

Hard Workers

Regulations and Standards Covered

The following is a list of Regulations currently covered by the Digital Auditor App, which includes but is not limited to;

FDA 21 CFR Part 820

21 CFR Part 820 provides requirements for a company to set policies, operating procedures, guidelines and objectives that will ensure product safety and effectiveness.

ISO 13485:2016

ISO 13485:2016 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

EU MDR

The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe. Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

ISO 14971

Requirements to address the application of risk management to medical devices.

IEC 62304

IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.

And many more..........

As Regulations and Standards are being updated, and new ones are being developed we will continue to offer the most up-to-date information to you, our new Partner.

Features of our Digital Auditor offering

Below is a list of a few of the features which are provided by our Digital Auditor app

Checklists of the most up-to-date Regulations and Standards

The Regulations and Standards within the Digital Auditor App will always be the most current as required by the Regulatory Agencies

Provides additional Insight

Digital Auditor will provide additional insights into the regulations and standards based on any additional available material(s), such as Guidance Documents, White Papers, Best Practices, etc.

Ease of Use

The main goal of the Digital Auditor App is to provide you with an “Intuitive Auditing Experience” which makes auditing easy; not only for seasoned auditors, new auditors, but also for employees with no auditing experience.

Safe & Secure

Digital Auditor App is safe and secure to use, utilizing the most up-to-date security protocols

Frequently Asked Questions

See below for answers to the most frequently asked questions, and if the answer you are looking for is not provided please select "Contact" above and we will respond as soon as possible.

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