FAMSTX.COM

firstchangeyourself.wordpress.com

FEAR… | Changes I Need

https://firstchangeyourself.wordpress.com/2015/01/13/fear

A continuous journey of introspection and efforts! January 13, 2015. We live in constant fear. Fear of future, fear of what other people think, fear of failure, fear of being left behind, fear of being alone, fear of losing, fear of unknown, and even the fear of love and happiness. You name it and you will find a fear associated with it. Why do we fear so much and how does this fear help us in any way? Now, that you are aware of your real deep fear, make this fear your personal drive for growth. Let ...

medscrum.com

In The Field with Andrew Ahn |

http://medscrum.com/blog/2014/11/02/field-andrew-ahn

In The Field with Andrew Ahn – Welcome to MedScrum. In The Field with Andrew Ahn. November 2, 2014. Meet regulatory professional and fellow industry blogger. Andrew Ahn, who has graciously agreed to be featured in MedScrum’s very first. In interview format,. Takes you inside the minds and working lives of industry professionals like you. Here’s our (edited) conversation:. Samsung Electronics R and D and manufacturing complex, Suwon, South Korea. Alex: How did you end up all the way over in South Korea?

medscrum.com

#2014RAPS Recap: What’s Simplexity and Why You Should Embrace It |

http://medscrum.com/blog/2014/10/06/2014raps-distillation-best-best-part-1

2014RAPS Recap: What’s Simplexity and Why You Should Embrace It – Welcome to MedScrum. 2014RAPS Recap: What’s Simplexity and Why You Should Embrace It. October 6, 2014. Regulatory Affairs Professionals Society. Put on by the Regulatory Affairs Professionals Society (RAPS). I focus here on one of them: the concept of simplexity. Is more than just another buzz word. What once resembled continual improvement now resembles continual regression. But first, simplexity Really? During his opening keynote address.

medscrum.com

ISO 13485 |

http://medscrum.com/essential-resources/iso-13485

ISO 13485 – Welcome to MedScrum. This international standard was designed with medical device manufacturers in mind. Pay this section a visit for current ISO 13485 regulatory and guidance resources. Join our Mailing List. Keep up to date with the latest news, and we'll send you something special as a thank you. Click here to subscribe. MedScrum is a resourceful and innovative regulatory affairs, quality assurance and HIPAA consultancy in the global medtech industry. In The Field with Andrew Ahn. Simply e...

medscrum.com

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out |

http://medscrum.com/blog/2015/05/07/best-document-management-practices-for-medical-device-startups-dont-cheap-out

Best Document Management Practices for Medical Device Startups: Don’t Cheap Out – Welcome to MedScrum. Best Document Management Practices for Medical Device Startups: Don’t Cheap Out. May 7, 2015. Tags: 21 CFR Part 11. The Cost of Cheaping Out. So why are so many young companies still struggling with. To “meet” their document management needs? Simply put: $ $. But look at it this way:. If your document controller earns, say, $60k a year, yet spends 20% of her time wrestling with nonconforming documents a...

medscrum.com

Product Snapshot: RegCheck |

http://medscrum.com/blog/2014/10/16/product-snapshot-regcheck

Product Snapshot: RegCheck – Welcome to MedScrum. October 16, 2014. As part of the inaugural. Here on MedScrum, I thought I’d feature a product that fits in nicely with the theme of simplexity explored in my previous post. The product I wish you to meet is RegCheck. RegCheck, the brainchild of Hurley Consulting Associates, is a cloud-based software tool launched this Fall. Securing customer data via Multi-factor Authentication (MFA). Supplies corrective action suggestions for identified deficiencies....

steveroseblog.com

Does Altruism Exist? | Finding Purpose

https://steveroseblog.com/2015/08/11/does-altruism-exist

Writings on Social Health and Belonging. Join 7,081 other followers. Top Posts and Pages. What Drives Human Behavior? Who are the 22 veterans? Military Betrayal, Civilian Isolation. How Veterans Experience Anomie. Why Existentialism Needs Sociology. The Normal Chaos of Love. The Need to be Needed. Suicide as a Social Phenomenon. Is licensed under a Creative Commons Attribution 4.0 International License. Based on a work at steveroseblog.com. August 11, 2015. March 15, 2016. October 26, 2015 at 4:00 am.

medscrum.com

The 6 Standards Makers of Standalone Medical Device Software Need to Know |

http://medscrum.com/blog/2014/09/05/standards-standalone-medical-device-software

The 6 Standards Makers of Standalone Medical Device Software Need to Know – Welcome to MedScrum. The 6 Standards Makers of Standalone Medical Device Software Need to Know. September 5, 2014. Diagnostic Mobile Medical Devices. ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes. Get to Know ISO 13485:2003. Back in 2012 suggests we’ll see further harmonization down the road). That said, you should still implement ISO 13485. Elsewhere–as in,. There are others, too,...

medscrum.com

Innovation in Healthcare and Beyond: Part 1 |

http://medscrum.com/blog/2014/09/23/innovation-healthcare-beyond-part-1

Innovation in Healthcare and Beyond: Part 1 – Welcome to MedScrum. Innovation in Healthcare and Beyond: Part 1. September 23, 2014. If when you think of innovation you picture a high-octane, frazzled-looking scientist who appears poised to electrocute himself while experimenting in his basement, you probably need to ease up on the Back to the Future. Marathons you’ve been indulging in. But these definitions of innovation don’t quite capture its spirit. Here is my attempt. The Spirit of Innovation. But ke...