Propel helps you bring products to market ridiculously fast
Propel helps manufacturing companies bring products to market ridiculously fast. Propel offers cloud PLM, PIM and QMS software that helps all your employees, partners and customers deliver the best ideas to market. Propel solutions support digital transformation and Industry 4.0 initiatives by enabling seamless collaboration within companies and with external design, manufacturing and selling partners.
Follow the Propel channel for the latest information and best practices for product development, quality management, product information management, product lifecycle management, and omnichannel selling.
Brad Hinke, Director of Quality Services & Validation at Propel
If your company is thinking about buying software to help with product development and manufacturing, validation is a critical step for complying with FDA 21 CFR Part 11 and Part 820. But many firms often lack detailed expertise and experience to make sure their non-product software is validated. With lack of resources and direction, how can you make sure your software is validated at a reasonable cost.
Brad Hinke, Director of Quality Services & Validation at Propel will host a live webinar and provide guidance and best practices from real-life lessons on validation. Brad has worked with both small and large medical device firms in all aspects of validation and implementation.
In this webinar, learn the following:
- what software needs to be validated and lessons learned from past validation efforts
- frameworks for approaching validation
- steps you must do to be compliant with the FDA.
Nicole Cannon, CEO, Cannon Quality Group & Miguel Tam, VP Marketing, PropelRecorded: Mar 7 201961 mins
Starting up a medical device company takes a lot of time, money and effort. In addition to the research, fundraising, product development, clinical trials, etc., the FDA and other regulatory agencies require a quality system to be defined and maintained. But when is the best time to implement a quality system in your medical device startup?
Recorded live in March 2019, Nicolle Cannon, CEO of the Cannon Quality Group hosted. Nicolle provided guidance and best practices to quality systems implementation and answer your questions.
Rick Altinger, Medical Devices Consultant ; Bradley Thompson, Epstein Becker & Green, Scott.Thiel, NavigantRecorded: Feb 19 201962 mins
Is your company developing or planning to develop a software product that meets the definition of a medical device?
In January 2019, FDA published its draft working model for a new precertification program, to supplement its medical device approval process for software which functions as a medical device. The FDA recognized that the traditional regulatory methodology is not well suited for the fast-paced, iterative-design development used for digital health software products.
Medical device expert and executive Rick Altinger led a panel discussion of the new digital health software regulations. and answered questions in this webinar recorded in February 2019. Learn the following:
- Is my company eligible for the program?
- What is the timeline for the new regulations?
- What does it mean to be pre-certified?
- What are the risks of non-participation?
Both PLM and ERP vendors tout capabilities for managing bills of materials (BOMs), changes, versions, files and other information related to your products. This makes some people wonder why you need both. The truth is PLM focuses on planning, while ERP focuses on execution.
What makes Propel different? Because we're built on the Salesforce platform, it's easy to tie customer, sales, engineering and operations together to improve the Engineer to Order process - and deliver products that customers will love.