PRECISION, VERACITY,  CREDIBILITY

Simplified, Defensible Compliance

LET’S GET STARTED!

Ask Us

 Do you have a Quality or Regulatory question? Our Quality & Regulatory affairs experts can help with no obligation from you. 

Weekly Journal

 Weekly insights on new Quality & Regulatory policies and practices  

About Us

We, the Verity Compliance team, are united by our mission: to help medical device manufacturers overcome regulatory challenges and bring safe products to market quickly.

Learn more about the team and about what drives us and is important to us.

Our Experience

We are a RESULTS-driven firm with 15 years of Quality & Regulatory Consulting and Industry experience, driving Simplified and Defensible Regulatory strategies for compliance in Medical Device/IVD Manufacturing, SW Development, Operations, and R&D.

We are skilled at working in the grey zone of Quality and Regulatory Compliance! Focusing on Patient Safety using a Risk-based approach in the Design and Development of Medical Devices/IVD.

Why Us?

Years of industry experience teach us the “Do’s” and “Dont’s” of Compliance. As we have traveled the world making with small, medium,  and large device manufacturers, the most common root cause of non-compliant firms is the inability to simplify processes and procedures to be compliant with State, Local, and Federal Laws and Regulations.

Team & Expertise

 Expertise includes

 

  • Regulatory affairs, FDA approval, CE-marking
  • Standards: IEC 62304, ISO 14971, IEC 62366, ISO 10993 and IEC 60601-1
  • Medical devices with embedded or stand-alone Software
  • Software engineering and software processes
  • Risk analysis, assessment, and management
  • Design Controls
  • Quality management: FDA 21 CFR part 820, ISO 13485:2016

Our team consists of highly specialized experts for

Regulatory affairs, FDA approval, CE-marking
Standards: IEC 62304, ISO 14971, IEC 62366, and IEC 60601-1
Medical devices with embedded or stand-alone Software
Software engineering and software processes
Risk analysis, assessment, and management
Requirements & human factors engineering and usability testing
Quality management: FDA 21 CFR part 820, ISO 13485:2016
FDA 483 and Warning Letter remediation efforts

Testimonials

Thomas is the experts expert. He has reduced our FDA review times by more than 60%, re-vamped the quality system to be something that supports growth through a “simple yet defensible” mindset, and has defended two companies from FDA and other notified body scrutiny. I’ve been in meetings with FDA Representatives that have praised him for his clear and concise explanation of the most complicated devices. Tom is the RA/QA leader that listens actively, and try’s to understand the commercial need, and helps guide both commercial and engineering teams towards success. He is the best RA/QA leader in the market. Hands down. – CEO

Thomas has been working as a Regulatory Specialist as part of a Class II Medical Device… Tom has served as Regulatory Lead in the Core Team at the program during this time. Tom has proven himself to be responsible, dedicated, and personable. He is more than capable of assimilating and performing new tasks, and so it is with great enthusiasm that I can personally recommend him for any position in the regulatory affairs space. Tom particularly impressed me with his multitasking abilities in a very dynamic environment, always data-driven and bringing compliant and new ideas to the Regulatory product issues that came in our way and helped us to overcome them compliantly. Tom has driven and completed multiple regulatory submissions under an exceptional environmental condition during the Covid 19 and he made sure that all requirements have been met and documented clearly.  – Sr. Program Manager

 

Few people have the opportunity to work with a strong leader like Tom. I had the pleasure of working with him for two years… I always admired his manner and communication with the team members and giving everyone the opportunity to prove their capabilities and grow. His open-door policy, calmness, and emphasis on the work-life balance were admirable. He was one of the best managers that I had the opportunity to work with and grow with. Any employee would be lucky to have Tom as a manager. – Sr. Quality Engineer

Working through the medical device regulations and approval process overwhelming and challenging.

Use these resources to get an introduction to the process and legal requirements for your medical devices.

Start

Get easy-to-understand introductory guidance about the approval process and legal requirements for legal devices.

Ask An Expert

Do you have a specific question? Our medical device and regulatory experts answer with no obligation for you.

Usability Testing

Ensure usability of your devices and compliance of your usability file with FDA and IEC 62366 regulations.

Discover Our Services

Making sure your documentation, quality management, and testing is aligned for the medical device approval experience doesn’t have to be as daunting as it may seem.

With our help, you not only have access to our expertise in document compliance, quality management, and usability testing. You will also be working out our team of regulatory specialists, auditors, engineers, and more.

Our services are specifically designed to help you pass medical device approvals and start selling your device.

Compliant Documentation

Produce documents to help get your medical device FDA and CE-approved.

Quality Management

Build an FDA (21 CFR part 820) and ISO 13485-compliant Quality Management (QM) System.

Usability Testing

Ensure usability of your devices and compliance of your usability file with FDA and IEC 62366 regulations.

Learn more about our training topics

With our training, you’ll be equipped to solve problems now and in the future as we give you the right concepts and models that are easy to implement.

Here are just a few reasons you’ll appreciating our training:

  • You have online access anytime, and anywhere, with step-by-step guidance for every step of the way.
  • High-quality, professional production with concise training that’s even fun to watch or attend.
  • Check yourself with tests to make sure that you’ve understood everything correctly.
  • Comprehensive with all documents, as well as templates for submission documents, ready to be used.

Documentation

Watch training videos and use our templates to create

b

Certification

Become an expert in medical device compliance (FDA)

k

Usability

Learn how to evaluate the safety and effectiveness