Medical Device Division

We Know Med Device

Quality Auditing was originally founded to serve the Medical Device, Pharmaceutical, and Biotech industries. The company has since grown to work in other industries and regulations.

The Medical Device Division was created to focus on our roots and provide you with the most qualified auditors & consultants who understand the healthcare industry from their extensive industry experience.

The Medical Device Division has auditors & consultants who are specifically qualified to work in the healthcare industry and dedicated support staff focused on the changing regulations and industry challenges so you can focus your resources elsewhere.

We hope you’ll explore the site to see the services we offer. We provide consulting support for the global marketplace, see below for a sampling of the standards and regulations we work with. Our team is truly the best in the business and we look forward to hearing from you so we can start the process of working together.

ISO 13485​
MDSAP
ISO 14971
21 CFR 820
GMP
EU MDD/MDR
21 CFR 210/211
CMDR

Our Experts Drive Your Competitive Advantage

Our people share perspectives gained from decades of dedicated industry focus and thousands of engagements. They speak your language. They understand your world. Their industry insights provide you with a truly distinctive edge.
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Global Reach, Local Presence

By having auditors located within driving distance of nearly clients (95%+ to date) – you spend your limited budget on hiring experts, not paying for airfare & hotels. This worldwide presence offers the benefit of rapid deployment and reduced lead-time for audit scheduling.

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Proven Healthcare Expertise

Our auditors & consultants are recognized as leaders in the medical device industry; many of have been instrumental in developing standards and implementing them at top device companies worldwide. They have credentials by industry leading organizations including RAPS, Stat-a-Matrix, Exemplar Global, ASQ, & IRCA (and more) and have a broad range of real-world experience, education, and backgrounds. For our clients, this translates to the best, most up-to-date knowledge of FDA & industry best practices and guidance on compliance requirements.

We utilize a proprietary system for qualifying and monitoring performance of our team to ensure that you always receive the highest level of service.

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Guaranteed Satisfaction

We’re so confident in our ability to meet your needs that we offer a 100% satisfaction guarantee. Simply put, if you aren’t happy with the service we provide, give us one chance to make it right. If we can’t get it right the next time – we will refund your money. Plain and simple.

Services

We provide Auditing & Consulting services to leading Medical Device, Pharmaceutical, and Biotech companies worldwide.

Internal Auditing

Supplier Auditing

Training

Compliance Consulting

Internal Auditing

Internal Audits are almost a universal regulatory requirement across the healthcare industry. Some of the top reasons our clients say they contracted us to conduct some of all of their internal audit includes:

  • Internal Resource Constraints: Whether you’ve lost key employees in your Quality Department or your internal staff is working on other priorities, we make it easy to ensure you meet your annual internal audit obligations.
  • Lack of Expertise: Auditing is a very specialized skill and research has found that many small organizations find it more cost effective to outsource their internal audit than expend the time and money to train auditors internally.
  • Insight into Industry Trends: We perform hundreds of audits per year and our auditors are able to advise clients on changes in the regulatory environment and best practices that are otherwise challenging to keep up with.
  • Conflicts of Interest: Many small organizations are unable to conduct internal audits without breaching the requirement that auditors are impartial/independent of the areas that are being audited. In larger organizations, we are sometimes brought in to eliminate potential political challenges that can be distracting in an audit.

Regardless of the reason, Quality Auditing LLC is well equipped to assist you with an internal audit of your QMS. The scope of the audit will be tailored specifically to your needs and requirements.

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Supplier Auditing

Auditing of suppliers to Medical Device and Biotech companies can be a daunting task. Quality Auditing LLC can conduct on-site supplier audits on your behalf to ensure that the activities you have contracted them for are being executed according to your requirements and applicable regulations.

Our Supplier Auditing Program helps to provide systematic and constant monitoring of your suppliers to mitigate potential supply chain risk and drive continual improvement activities. The scope of our supplier auditing services ranges from a single audit to the complete management of an entire supplier auditing program, from scheduling the audits, to closure of audit nonconformances. The proximity of our auditors to your suppliers anywhere in the world ensures that these audits can be with executed quickly, with local experts who literally speak the language of your suppliers and know the culture
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Training and Compliance Consulting

Discover unparalleled Training & Consulting solutions tailored for the medical device industry at Quality Auditing. We specialize in QMS Implementation, Training, and Consulting, empowering organizations to elevate performance, mitigate risks, and steer clear of the detrimental impacts of subpar quality. We guide you through adherence to standards & regulations, including ISO 13485, FDA QSRs, the MDSAP Audit Model, and more, equipping your team with essential tools and knowledge to navigate regulatory complexities, optimize processes, and achieve unparalleled quality management excellence. Partner with us to unlock industry-specific insights, practical strategies, and customized solutions designed to drive continuous improvement and regulatory compliance. Stay ahead in the competitive medical device landscape with Quality Auditing.
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Trusted By

Mettler Toledo
Millipore Sigma
NAMSA
Nelson Labs
Oliver
Olympus
Pace
ParkerHannifin
QuidelInc
Reckitt
Seimens
SGS
Sotera
Steris
TE_Connectivity
Tekni-Plex
Teleflex
Troemner
Amcor
Aramark
Boston Scientific
ColeParmerLLC
Coloplast
Dr.Scholls
Dupont
Eurofins
Fluke
Fresenius
GE
IDEX
JABIL
Konica-Minolta
Medela

Medical Device auditing best practices customized for you

Throughout our many years working in the Medical Device industry, we have created and refined a systematic, phased approach to regulatory compliance auditing based off of ISO 19011:2018 Guidelines for Quality Management Systems Audit and our experience in FDA and other global regulations.

Our goal is ensure consistent delivery of top quality service to ensure we meet and exceed your quality objectives. Experience has shown that successful partnerships require clear and constant communication before, during, and after an audit. The typical process we follow is shown below:

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Want to talk to us directly?
Give us a call!

Please call us at 612-208-7845

The type of information we’ll want to discuss when you call includes:

  • Type of service
  • Location
  • Potential Service Date(s)
  • Any other special needs.

 

If you’re unsure of anything – that’s ok!

Our experts will help talk through the process.

Request a quote by filling out the form below and we will contact you as soon as possible


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Quality Auditing LLC is the Gold Standard of Auditing.

About

Industries

Quality Auditing, LLC

Corporate HQ:
225 South 6th St. Suite 3900
Minneapolis, MN 55402

612-208-7845
support@qualityauditing.com

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