You will get a Quality System Manual for your medical device company
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Top Rated
Project details
You will get the help you need to make sure your medical device company is compliant with regulations and audit ready. The basic model starts with a fully editable template for an ISO 13485 and 21 CFR part 820 compliant quality system manual. You can add, delete or change any section or procedure to suit your company's needs. The quality manual template is written in Microsoft Word so it is easy to edit.
Though the template can help save time and ensure you're headed in the right direction, filling it out completely--and ensuring each section is up to par--will take work. Furthermore, one could get tripped up by regulatory language or have questions best answered by a consultant. If you need a bit more extra support getting your manual ready for use and potential audits, the standard model might be right for you.
The advanced option will require the least amount of time and effort from you because I will be doing all the drafting and writing. You will provide input on your company's specific procedures, I'll be the one putting it all together in a format that meets standards. This is the the one that will get you up and running with the least amount of hassle.
Though the template can help save time and ensure you're headed in the right direction, filling it out completely--and ensuring each section is up to par--will take work. Furthermore, one could get tripped up by regulatory language or have questions best answered by a consultant. If you need a bit more extra support getting your manual ready for use and potential audits, the standard model might be right for you.
The advanced option will require the least amount of time and effort from you because I will be doing all the drafting and writing. You will provide input on your company's specific procedures, I'll be the one putting it all together in a format that meets standards. This is the the one that will get you up and running with the least amount of hassle.
Project Type
Business ConsultingWhat's included
| Service Tiers |
Starter
$1,000
|
Standard
$1,400
|
Advanced
$5,000
|
|---|---|---|---|
| Delivery Time | 2 days | 14 days | 21 days |
Number of Revisions | 0 | 0 | 1 |
Optional add-ons
You can add these on the next page.
Additional Revision
+$500
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About Tian
Lab to Market Consulting for BioTech and Med Device Startups
100%
Job Success
Reno, United States - 7:33 am local time
*Delivering Expertise in Class II Medical Devices & IVDs*
Core Services:
1. Regulatory Compliance & Quality:
►Customized strategies for FDA Compliance, Import Compliance, and Quality Management System (QMS).
►Deep expertise in regulatory submissions, notably 510(k) and pre-submission.
►Thorough guidance on ISO 13485:2016 standards, augmented by hands-on auditing experience.
►A comprehensive framework to assure your products maintain unwavering regulatory compliance.
2. Science/Technology-focused Market Research & Market Strategy:
►Competitive Market Analysis
►Unmet Needs Assessment
►Due Diligence
►Competitive Differentiation Strategies
►Technology Landscape and Market Research
Meet Dr. Tian Yu:
Tian embodies a combination of scientific rigor and business strategic acumen, marking her as an essential partner in the Medical Device sector.
Educational Portfolio:
- A rare blend of a Ph.D. in molecular sciences and an MBA, manifesting a holistic view of both scientific and business landscapes.
- Trailblazing research on assay development and precision medicine, showcases her commitment to advancing scientific understanding.
Professional Endeavors:
- Proven experience in guiding medical device and biotech companies through the regulatory maze and into market leadership.
- Hands-on leadership in steering medical innovations that address critical societal challenges, with a highlight on devising solutions in the IVD and liquid biopsy domain.
Certifications:
- ISO 13485:2016 Lead Auditor and Internal Auditor, BSI.
- TL-Leading Management Systems Audit Teams (ISO 19011:2018), BSI.
- CERTIFIED MEDICAL DEVICE AUDITOR (CMDA), ASQ.
- QMS Training for Medical Devices: FDA QSR and ISO 13485, Oriel STAT A MATRIX.
- Good Clinical Practice Course with a US FDA focus, CITI program.
- Innovating in Health Care Certificate, Harvardx through edX.
When venturing through the intricate pathways of the Medical Device industry, Dr. Tian Yu's blend of regulatory expertise and market strategy can contribute to your path to success. Reach out today and let her help you navigate the journey with confidence and achieve your goals.
Steps for completing your project
After purchasing the project, send requirements so Tian can start the project.
Delivery time starts when Tian receives requirements from you.
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Revisions may occur after the delivery date.
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