Case Studies Establishing Design Control Processes for Today and the Future

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	Establishing Design Control Processes for Today and the Future

Establishing Design Control Processes for Today and the Future

Technology Category	Functional Applications - Enterprise Resource Planning Systems (ERP) Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Product Research & Development Quality Assurance
Services	System Integration Training
Challenge	RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. Innovation drives the team’s product development. At the same time, RefleXion adheres to the highest quality and compliance standards for life sciences companies. Almost from the beginning of product design, RefleXion knew they needed the support of a product realization platform that would grow with the team, the product, and their path through medical device compliance. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months. With fast team growth and continued product design progress, RefleXion needs everyone in sync. Read More
About Customer	Imagine a cancer treatment scenario where a medical device detects, analyzes, and treats multiple tumors in a single treatment. RefleXion is pursuing a valiant mission to impact the lives of millions of cancer patients around the world with the first biology-guided radiotherapy (BgRT) system. In support of the mission, RefleXion has chosen Arena as the system of record for design and quality controls. RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months. Read More
Solution	RefleXion began with Arena to manage parts and bills of materials (BOMs) and standard operating procedure (SOP) documentation rollout and then continued to utilize Arena for product revision control. The company uses Arena’s document, quality, training, and project management capabilities for product processes, including nonconformance reports (NCRs) and device history files (DHFs) organization. Arena is also integrated with the company’s QAD enterprise resource planning (ERP) system for purchasing processes. Summing up RefleXion’s choice, Dipali says: 'Arena is a powerful tool, optimized to control parts and BOMs, and additionally allows review and approval of design and quality system documents with integrated training. While other systems offer similar functionality, the ease of configuration and the validation quick start package made Arena the right choice for RefleXion.' Read More Log in to view content
Contents

Technology Category

Functional Applications - Enterprise Resource Planning Systems (ERP)

Functional Applications - Product Lifecycle Management Systems (PLM)

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Product Research & Development

Quality Assurance

Services

System Integration

Training

Challenge

RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. Innovation drives the team’s product development. At the same time, RefleXion adheres to the highest quality and compliance standards for life sciences companies. Almost from the beginning of product design, RefleXion knew they needed the support of a product realization platform that would grow with the team, the product, and their path through medical device compliance. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months. With fast team growth and continued product design progress, RefleXion needs everyone in sync.

About Customer

Imagine a cancer treatment scenario where a medical device detects, analyzes, and treats multiple tumors in a single treatment. RefleXion is pursuing a valiant mission to impact the lives of millions of cancer patients around the world with the first biology-guided radiotherapy (BgRT) system. In support of the mission, RefleXion has chosen Arena as the system of record for design and quality controls. RefleXion Medical is on a fast-paced, high-growth path with its mission to provide better options for cancer patients worldwide. The company’s growth has been aggressive, even by startup standards, tripling the team in 18 months.

Solution

RefleXion began with Arena to manage parts and bills of materials (BOMs) and standard operating procedure (SOP) documentation rollout and then continued to utilize Arena for product revision control. The company uses Arena’s document, quality, training, and project management capabilities for product processes, including nonconformance reports (NCRs) and device history files (DHFs) organization. Arena is also integrated with the company’s QAD enterprise resource planning (ERP) system for purchasing processes. Summing up RefleXion’s choice, Dipali says: 'Arena is a powerful tool, optimized to control parts and BOMs, and additionally allows review and approval of design and quality system documents with integrated training. While other systems offer similar functionality, the ease of configuration and the validation quick start package made Arena the right choice for RefleXion.'

Impact #1	Cycle-time reductions
Impact #2	Confidence in design control
Impact #3	Every single person at RefleXion uses Arena, ensuring everyone is in sync.

Impact #1

Cycle-time reductions

Impact #2

Confidence in design control

Impact #3

Every single person at RefleXion uses Arena, ensuring everyone is in sync.

Benefit #1	Tripled the team in 18 months.

Benefit #1

Tripled the team in 18 months.

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Overview

Establishing Design Control Processes for Today and the Future

Operational Impact

Quantitative Benefit