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Consolidation helps Megadyne successfully comply with multiple regulatory agencies

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Electrosurgical devices are commonly used to help surgeons make precise cuts, as well as limit blood loss during a surgical procedure.

Numerous medical facilities in 72 different countries use electrosurgical devices designed and manufactured by Megadyne Medical Products. Megadyne Medical Products has a global customer base, which means it must comply with the requirements of multiple regulatory agencies, including:

Megadyne’s challenges with a paper-based system

Before MasterControl, Megadyne used a paper-based system for document control and change control processes. “A paper-based system required numerous processes to meet quality regulations both within and outside the US,” said Haven McCall, vice president of quality and regulatory affairs.

When routing documents, it discovered that approvers from different departments were making changes. This caused delays because the revised documents needed to be routed and approved again.

“The paper-based system was constraining for us. It soaked up a lot of time, money and resources just to make a minimal change,” said McCall.

Megadyne also experienced delays during audits. It had stacks of banker’s boxes for storing documents. When auditors requested specific documentation, it needed to sort through the boxes to find it.

Implementation of MasterControl

In July 2014, Megadyne went live with MasterControl. It implemented the Change Control solution and found that it made its life much easier. “Working with MasterControl support was pretty painless,” said Quaid Reynolds, IS manager. “They are willing to jump on a call and work with you. We have always quickly gotten to the source and resolved any issues we’ve had.”

Solutions implemented at Megadyne

Change Control management

Megadyne uses the Change Control module to coordinate its document review and approval tasks. “We immediately found that we were able to eliminate some of the challenges we had with both routing and looking for documents,” said McCall.

Training management

Megadyne uses the training module to create training based on employees’ roles. When employees are hired, they receive a training packet, then they complete an examination to ensure they are competent to perform the work. The entire process is captured automatically in MasterControl. “It’s nice because it’s something we don’t have to manage. We let the system do it,” said McCall.

Complaints management

Before MasterControl, Megadyne used a lot of paper and folders for its complaint processes. It had three full-time coordinators oversee all of the complaint paperwork. MasterControl significantly reduced the time and number of staff required to manage complaints.

Non-technical personnel maintain MasterControl

After implementing MasterControl, it needed an on-site employee be the system’s administrator. Its document control manager filled that role. “This person doesn’t have an IT background, she has a background in document control and training,” said McCall. “It was easy for her to learn the system and handle any issue we’ve needed help on.”

What Megadyne didn’t realise it was missing

Since implementing MasterControl Megadyne immediately noticed several process improvements.

Automating routing, collaborating and approving documents

“One of the neat things we found is that you can route and approve documents in parallel. With a paper-based system, it was a serial process. Documents moved through many reviewers one at a time. If there was a change, the routing process had to be repeated,” said McCall.

Timely turnaround for change orders

McCall said approving documents went from weeks and months to days. Now it has more visibility into where a change order is located, who it is sitting with and its status.

Document traceability

“Another excellent advantage is traceability. In two years we lost 28 change order packets. If you can imagine the amount of time and resources that went into revising a quality system document only to have it get lost. It was incredible and it significantly impacted our business. With MasterControl, we no longer lose change order packets,” said McCall.

Time back in its day

MasterControl reduced the administrative and busy work with change control. This allows it to focus more on business-critical tasks.

MasterControl helps Megadyne comply with multiple regulatory agencies

Megadyne is able to coordinate and meet the compliance standards of all the different regulatory environments around the world. “One of the main reasons we go with MasterControl is because it helps us consolidate all the requirements from the different regulatory agencies,” said Rob Farnsworth, CEO of Megadyne Medical Products.

Audit experience with MasterControl

Megadyne had around 10 audits within a year of implementing MasterControl. “We found that the audits went smoother because we were able to quickly find the documents the auditors requested,” said Farnsworth. “Auditors acknowledge that we have things better under control, and our quality events reduced significantly since implementing MasterControl.”

How MasterControl helps Megadyne improve its life changing products

At Megadyne, quality is emphasised throughout the organisation. “MasterControl makes it possible for us to focus time and energy on designing and creating products that could have a great effect in the marketplace,” said Farnsworth. “We make life better for clinicians and ultimately the patients.”

Conclusion

With MasterControl, Megadyne confidently demonstrates to regulatory bodies throughout the world how it complies with record retention, documentation and change control. “MasterControl makes all processes more efficient, which is the key to doing things that bring value to your customers, employees and stakeholders,” said Farnsworth.

To discuss more please visit us at MD&M West show, CA Booth #2448 between 07- 09 February 2017

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Contact us:

P: +1 801 942 4000 ll W: www.mastercontrol.com  ll E: info@mastercontrol.com

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