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Kapstone Medical Blog
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- 19 MINUTE READ
- 05/26/2020
Using Competitor Research Throughout the Medical Device Product Development Lifecycle
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- 11 MINUTE READ
- 01/16/2020
European MDR: EUDAMED Database and UDI
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- 17 MINUTE READ
- 01/08/2020
EU MDR and Post Market Surveillance: What You Need to Know
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- 11 MINUTE READ
- 12/18/2019
EU MDR: How Clinical Evidence Requirements Affect Medical Device Approvals
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- 14 MINUTE READ
- 12/12/2019
European MDR: Product Portfolios and Technical Documentation
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- 11 MINUTE READ
- 12/04/2019
European MDR: Notified Bodies
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- 17 MINUTE READ
- 11/21/2019
European MDR: How do we get ready for MDR?
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- 12 MINUTE READ
- 11/13/2019
What is European MDR and Why It happened, Timelines for Compliance
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- 06/21/2022
How and When to Register Your Establishment with the FDA & Who Needs to Register
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- 11/12/2020
What is an ISO certification and what role does it play in the medical device industry?
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- 01/03/2024
Implementing design controls: Medical device quality, compliance, & traceability
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- 08/02/2023
Using eSTAR and PreSTAR Templates
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- 06/06/2022
Annex XVI: What to do if Your Non-Medical Product is Subject to Regulation Under MDR
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- 08/17/2018
How GDPR Applies to Medical Devices
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- 03/31/2020
How Outsourced Regulatory Affairs Consultation Can Save Your Medical Device Company Time and Money
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- 06/13/2022
The Top 5 Features Medical Device Companies Request for Their Quality Management Systems
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- 04/23/2021
Product Design & Development
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- 04/23/2021
Why Kapstone?
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- 06/01/2014
A Roadmap to Success for Surgeon Inventors – Part 1: From Concept to Commercialization
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- 04/23/2021
Regulatory Strategy
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- 08/12/2020
5 Ways Medical Device Development Companies Can Save Money When Developing Products
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- 12/04/2019
European MDR: Notified Bodies
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- 05/15/2020
Solving The Top 4 Challenges Medical Device Companies Face When Developing New Products
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- 05/26/2020
Using Competitor Research Throughout the Medical Device Product Development Lifecycle
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- 01/29/2021
A Roadmap to Success for Surgeon Inventors - Part 1: From Concept to Commercialization
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- 04/23/2021
Quality Assurance
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- 12/26/2018
FDA Approves First Continuous Glucose Monitoring System Not Requiring Blood Sample Calibration
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- 06/22/2017
The Next Generation of 3D Printing
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- 05/24/2021
A Roadmap to Success for Surgeon Inventors - Part 2: Is Your Next Product Idea Viable? The Case for Feasibility Studies
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- 04/23/2021
Manufacturing Solutions
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- 04/23/2021
The Steps to a 510k
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- 12/07/2018
Heart Implant, 3D Printed to Order
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- 12/20/2018
FDA's ASCA Pilot Program
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- 10/22/2015
What You Missed Last Month (September 2015 Edition –Medical Device & 3D Printing)
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- 04/06/2018
8 Trends For 3D Printing in Spine
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- 08/20/2014
A Roadmap to Success for Surgeon Inventors, Part 4: The Cost of Developing Your Idea
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- 07/18/2014
A Roadmap to Success for Surgeon Inventors, Part 3: Technologies for Development of Your Ideas
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- 07/01/2014