A tested 6 part formula to write and submit compliant European Union technical documentation.
Have you made the decision to sell your product in the European Union and are wondering how to obtain product certification?
Are you wondering how technical documentation is written and how to get started, no matter the size of your company?
What if it was easy to do and took just a couple of hours to get started with equipment you already own and know how to use?
The cQMS Formula: EU Technical Documenation is a book that teaches entrepreneurs, business owners and CEOs, RA/QA professionals, engineers, consultants and creative types how to write and submit EU technical documentation so they can sell medical devices in the European Union.
My primary goal in writing this book is that people in the medical device industry can read it, enjoy it, and walk away with new information. The solutions found in this book are simple. RA/QA is complicated enough, and this book should be read by people with all backgrounds (possibly with no RA/QA background or understanding) so simple solutions are always best. Everything is compliant. So much complexity in industry and compliance gets shoved to the back seat of the car. Compliance should drive the car! And most importantly, the solutions and examples are real. Real clients (with names removed), real projects, and real solutions to problems. Nothing make-believe in here. Simple. Compliant. Real. It shouldn't be any other way.
My secondary goal in writing this book is to make it actionable. When I was self-educating, I was amazed at each book that sent me on an endless learning expedition to other books. I wanted it simple and I wanted to implement now. This book is structured so that you have information to implement now. Steps one and two are preparation and can be completed within 5 days. The second, third and fourth parts are writing the technical documentation and can be completed within 5 weeks. The last step can have to company ready for a successful certification in 5 months. It's the actionable book I always wish I had found and read!
Have you made the decision to sell your product in the European Union and are wondering how to obtain product certification?
Are you wondering how technical documentation is written and how to get started, no matter the size of your company?
What if it was easy to do and took just a couple of hours to get started with equipment you already own and know how to use?
The cQMS Formula: EU Technical Documenation is a book that teaches entrepreneurs, business owners and CEOs, RA/QA professionals, engineers, consultants and creative types how to write and submit EU technical documentation so they can sell medical devices in the European Union.
My primary goal in writing this book is that people in the medical device industry can read it, enjoy it, and walk away with new information. The solutions found in this book are simple. RA/QA is complicated enough, and this book should be read by people with all backgrounds (possibly with no RA/QA background or understanding) so simple solutions are always best. Everything is compliant. So much complexity in industry and compliance gets shoved to the back seat of the car. Compliance should drive the car! And most importantly, the solutions and examples are real. Real clients (with names removed), real projects, and real solutions to problems. Nothing make-believe in here. Simple. Compliant. Real. It shouldn't be any other way.
My secondary goal in writing this book is to make it actionable. When I was self-educating, I was amazed at each book that sent me on an endless learning expedition to other books. I wanted it simple and I wanted to implement now. This book is structured so that you have information to implement now. Steps one and two are preparation and can be completed within 5 days. The second, third and fourth parts are writing the technical documentation and can be completed within 5 weeks. The last step can have to company ready for a successful certification in 5 months. It's the actionable book I always wish I had found and read!
