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August News & QA/RA ISSUE: 3 approaches to an FDA inspection, 62366-1:2015 vs Applying Human Factors, New FDA final rule on symbols for device labels, ISO 13485:2016 changes will impact your QMS, 5 sensors your wearable needs, FDA data and trends, New European Medical Device Regulations, OTOHARMONICS, September Event Calendar


Message from the President

 

Welcome to our third annual QA/RA issue. QA/RA is such a complex topic, this issue always leads the pack in readership and shares. 

Last week I formally announced management changes to the StarFish team before heading out for a cycling vacation with my family. I'd like to share that news with you.
 
John Walmsley will be taking on the new role of Chief Operating Officer.  This is an expanded responsibility for product development, manufacturing, day to day QA, internal finance, HR and facilities.  A big congratulations to John. 
 
Mike Lubben will be stepping up into the Director of Product Development role and will join the management team.
 
Within product development:
  -Mark Drlik will be the new Functional Manager for mechanical engineering
  -Nick Allan will be the new Functional Manager for biotech (a new role)
  -Andrew Morton will be new Functional Manager for project management
 
I will continue to act as CEO with responsibility for StarFish Group (eg ViVitro), Sales, Marketing, group finance, and QA. 
 
Congratulations to all.  I am so impressed by the quality of leadership that has been developing within StarFish in the past few years and am grateful that these amazing people have stepped up when offered the opportunities. 

Have a great summer and as always, thanks for reading.

Scott Phillips, President

 2016 QA/RA ISSUE


Cam Neish leads employee training for FDA inspection


3 real–world approaches to an FDA inspection

By Vesna Janic 

As a contract design & development and a manufacturing firm, StarFish Medical is subject to multiple registers’ audits  and client audits. We are also inspected by the FDA every 2 to 3 years for client medical devices marketed in the US.

At the end of 2015 one of our manufacturing clients was inspected by the FDA, and 3 months later another client was inspected. Both of the clients and StarFish each ended up with a Form 483 containing 3 observations.

Cam Neish and I will be speaking on this topic at the October BC RAPS event in Vancouver.  Details will be posted in our September newsletter. 

I've also written a series of blogs that outline our inspection preparation strategies (very different for each one!), the inspection outcomes, and lessons learned.

This first blog covers inspection participation strategies.

 

Read More 


 

StarFish QA/RA team expands to meet growing client needs

L-R:  Rob Keur, Vesna Janic, Virginia Anastassova, Cam Neish, and Mike May.  Not pictured: Savannah Hari

We recently added two junior QA specialists to the QA/RA team to support growing product development and manufacturing projects. 

Savannah Hari is a recent UVic graduate with a B.Sc. Chemistry for the Medical Sciences. Michael May graduated last spring from UBC with a B.A.Sc in Materials Engineering. Both have contributed articles to this issue.


2nd Annual ComplianceOnline Medical Device Summit 2016

Scott Phillips will present Digital Health and Medical Devices on September 15-16, 2016, at ComplianceOnline Medical Device Summit in San Diego CA. Register Here

2016 INTERFACE Health Summit

Scott Phillips will share how digital health is viewed by medical devices companies on September 28 at the 2016 INTERFACE Health Summit in Vancouver BC. Register Here

Society of Clinical Research Associates (SOCRA) 2016 Annual Conference

Scott Phillips presents The State of Innovation in the Canadian Medical Device Industry at the 2016 Annual Conference of SOCRA on September 30 in Montreal QC. Register Here

QA/RA Client Feedback

OTOHARMONICS

 
Photos from July

StarFish Sightings

 
Celebrating in Victoria

Summer picnic 2016




I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.

Their knowledge is outstanding; A lot of other QA people simply pretend to know regulatory details and implications while the StarFish team really does. And they are not afraid to admit when additional research is needed.

Michael Baker
President & CEO
Otoharmonics Corporation

The Levo System from Otoharmonics:

Is specifically designed for use during sleep when the brain is especially responsive to habituation

Can identify the unique tinnitus sound of each individual

Allows you to hear the sound the patient lives with

Has FDA clearance, CE mark, CSA certification and ISO 13485 2013 Edition

Tracks patient use and response to therapy using smart technology

Exclusively integrates the Tinnitus Functional Index to measure and monitor tinnitus impact

Uses custom ear buds & Apple digital devices

 




Carmen and Michael Bidu discuss INTERFACE 2016 and #IHCX2016 with Scott Phillips during their recent visit to Victoria,
New building signs are just part of our updated look. Have you visited StarFishMedical.com lately?


Garrick, Chris and Jess work on the new StarFish Culture video.

Heidi, Logan and Vesna enjoyed rockin' in style at the VIATEC Rock The Shores cabana.
 
 











It wouldn't be a StarFish and ViVitro summer picnic without v-ball, dogs, kids of all ages, and a guy shooting professional video complete including a steady cam and a drone.