Mythical Medical™ is a manufacturing company dealing with the revolutionary changes in the medical device laws in Europe.

MYTHICAL MEDICAL™

David R. Rutledge provides a fascinating peek behind the veil of mystery surrounding the world of medical device manufacturing. A refreshingly fast, fun, yet very informative read!
~ Victoria Andre King, author of The Führer Must Die

ABOUT THE BOOK

Kai-Lin Liu’s career in the medical device industry is at a turning point. Little does she know that her entire world is on the cusp of significant change. Her qualities have attracted the attention of senior leadership in more ways than one, but relationships with colleagues may either make or break her chances for advancement. Will she be able to muster the determination to break through her own self-doubts in order to shatter the glass ceiling and earn her place as an international innovator?

A successful medical device industry consultant delivers a key-note presentation at an international conference in Brussels, unaware that it will have life-changing consequences for many. Innovations within the medical device sector are challenged by shifting regulations. Kai-Lin and several of her new colleagues are in attendance. While her nemesis, Project Manager, Ada Aarons, scoffs at impending change, Kai-Lin is determined to find solutions.

Kai-Lin’s employer Mythical Medical, a diverse medical device manufacturing corporation, is looking to overcome growing pains for dynamic expansion into the international market. On the cusp of a leadership shift, the board monitors revolutionary device approval process developments in Europe. They have attracted an impressive multicultural team to their Golden Valley, USA headquarters, but departments are siloed. New senior leadership notices a lack of innovation, cohesion, and coordination: enter the Consultant! Across departments the team is challenged to grow and make a difference together before it’s too late.

The young team members are individually forced to confront uncomfortable past experiences and view them from a growth perspective. Unexpected alliances grow from conflict, but will they successfully meet the challenges that stand in the path of Mythical Medical emerging as an industry innovator? Kai-Lin and her senior leader, Faraj Mishra, discover that their destinies are intertwined in ways they had not previously imagined. Will the consultant be able to successfully guide key staff into becoming their best professional selves?

Follow this story of intrigue and redemption within an up-and-coming manufacturer, Mythical Medical.

AUTHOR - DAVID R RUTLEDGE

After decades spearheading innovation and navigating clinical, regulatory, and quality minefields in the pharmaceutical and medical device industries, David R Rutledge decided to transition into consulting. In that capacity, he has made a difference across a broader spectrum, influencing decisions by educating the people who make them. Mythical Medical™ is his maiden effort to put the fruit of his experience into an informative and entertaining narrative. Fact and fiction intersect to reveal the truth about this vital and, at times, controversial industry.

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About us

25 years’ global experience with agencies such as US FDA, Brazil ANVISA, Mexico COFEPRIS, NMPA (China FDA), S Korea Ministry of Food and Drug Safety, Hong Kong, Malaysia, Health Canada, Australia TGA, Thailand FDA, Japan PMDA, EMA, Saudi FDA, CDSCO of India and several Notified Bodies. Qualified EU Person Responsible for Regulatory Compliance (PRRC) 

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