ClearMark

A Quality Management System for medical technology

ClearMark is an electronic QMS specifically developed for Medical Device entrepreneurs, designers, and manufacturers. With a QMS that supports your business and organizes your team, products are developed on schedule and within budget. At ClearMark we believe your QMS should do more than just ensure compliance to ISO 13485 and 21 CRF 820; it should support your project goals from concept to post-market.

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ClearMark Software Solutions

ClearMark’s modular system can be customized to suit your business needs. With 21 CFR 11 compliant electronic signatures and a full set of standard operating procedures, The Fundamentals provides a turnkey solution for your QMS needs. Designed for seamless ISO 13485 and FDA audits, ClearMark provides both the workflows and Standard Operating Procedures you need to ensure compliance at all phases of your product lifecycle.

The Fundamentals

Document Control

Change Control

Training

Premarket

Design Control

Risk Mangement

Supplier Management

Audits

Postmarket

Complaints

CAPAs

NCRs

Seamless Design Control

Teamwork and organization lead to efficiency in design controls. Our patent pending Design Control Module provides the platform for your design and development implementation. ClearMark QMS offers cutting edge Design Control Planning and Implementation workflows to ensure your team has full visibility to and tracking of all elements of your project. With your team aligned on clear strategic objectives, projects are completed faster and easier in the Design Control workflow.

Comprehensive and Current

Regulations and international standards are constantly changing and updating procedures takes time and attention. With ClearMark, you can use your existing SOPs or those provided with the system. Either way, you’ll receive annual procedure updates to ensure that you will always be compliant.

Service

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Whether your company is just entering the medical device market or you’re an established business in need of regulatory or quality support, our team knows what it takes to achieve your business goals.

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Reach out for more information on consulting services or schedule a consultation

Consulting Information

About

At ClearMark we believe quality is the framework for business and product excellence. ClearMark is built to ensure compliance, expedite your pathway to market, and coordinate your team. Let our team show you how.

Management Team

Alison Sathe

CEO & Founder

Alison is a biomedical Engineer with more than 15 years in Regulatory and Quality Assurance for medical technology. As founder of Regulatory Mark, Alison finds solutions for her clients most challenging Regulatory and Quality needs. ClearMark is the result of observing the difficulties her clients faced with traditional Quality Management Systems. Alison believes Quality Systems should be an asset for your company, facilitating teamwork and clarity in your design and development projects and ensuring safe and effective products every step of the way.

When she's not immersed in medtech, Alison enjoys spending time with her husband and four daughters.

Adam Bothwell

CTO & Co-Founder

Adam is a Cincinnati born, self-taught software engineer obsessed with technology. Adam began his career at age 15, founding one of the first anti-spyware companies in the world and brings more than 15 years of professional software development experience to ClearMark. Throughout his career, Adam has consulted with numerous Fortune 1000 companies providing software architecture and engineering services primarily on the Microsoft stack. Adam specializes in building SaaS/PaaS systems on Microsoft Azure and has worked on several highly transactional multi-tenant systems in the last 5 years.

When Adam isn’t online, he finds himself cheffing in the kitchen, traveling the world or losing dozens of golf balls on the course.

Steve Fedak

Director of UX

Steve, a Cincinnati native, has been working as a Front-End Developer and System Analyst for various marketing agencies for the past 11 years. His passion for site design, animation, and architecture has fueled his career development. Steve, like Adam, started self-taught by making websites for his gaming guilds and clans. In other words, he's a huge nerd.

The Red River Gorge is Steve's second home. He enjoys spending time during the spring and fall seasons rock climbing. Don't worry, he is super safe. None of the #freesolo stuff.

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