Browse categories
Explore
Fiverr Pro
English
$
USD
I will develop iso 13485 quality manual and sops for medical device
Muhammad A
About this gig
Welcome!
Are you looking for an experienced Quality Management professional to help improve your management system or prepare for certification?
With 10+ years of experience in Medical Devices, Surgical Instruments, and Pharmaceutical industries, I provide practical consulting services aligned with international quality and regulatory requirements.
My services include:
ISO 13485:2016 Quality Management Systems
ISO 9001:2015 Quality Management Systems
US FDA 21 CFR Part 820
EU MDR 2017/745 Compliance
Internal Audit Support
Gap Analysis
CAPA Review
Quality Documentation Review
SOP and Quality Manual Guidance
You will receive:
Professional compliance review
Practical improvement recommendations
Summary report
Confidential handling of your documents
Timely communication and delivery
Whether you are preparing for certification, regulatory inspections, or improving your Quality Management System, I am here to support your project with reliable and practical solutions.
Please contact me before placing an order so we can discuss your requirements and ensure the best solution for your organization.
Get to know Muhammad A
Muhammad A
Quality Management Expert: ISO 9001, 13485, US FDA, EU MDR, GDP, cGMP
- FromPakistan
- Member sinceApr 2022
Languages
Urdu, English, German
Hi, I’m Muhammad Ali, presently offering QMS services to German Company (Remotely from Pakistan) as a Quality Management Representative. My professional career of 11 years centers on establishing and implementing Policies, Corporate Procedures and compliance systems based on International Standards, US FDA and EU Regulations.
Services I Offer:
- ISO, US FDA, EU GDP, cGMP Documentation & SOP Development
- Quality Manual Preparation
- Internal Audits & Gap Analysis
- CAPA & Risk Management
- Supplier Qualification & Audit Support
- QMS Training & Improvement
FAQ
Which standards do you support?
I provide consulting and documentation support for ISO 13485:2016, ISO 9001:2015, US FDA 21 CFR Part 820, EU MDR 2017/745, GMP, and GDP requirements.
What do I need to provide before placing an order?
Please share your company details, products or services, applicable standard, current documentation (if available), and your project objectives. This helps me provide the most suitable solution.
Do you sign a Non-Disclosure Agreement (NDA)?
Yes. I understand the importance of confidentiality and am happy to sign an NDA before reviewing any sensitive documents.
Will the documents be customized for my company?
Yes. Every document and recommendation is tailored to your organization's products, processes, and regulatory requirements. I do not provide generic templates unless specifically requested.
Can you help prepare us for ISO certification or regulatory inspections?
Yes. I can assist with gap analysis, documentation review, internal audits, CAPA, and recommendations to help your organization prepare for certification or regulatory inspections.
Should I contact you before placing an order?
Yes. Please send me a message before placing an order so we can discuss your requirements, confirm the scope of work, and choose the most appropriate package.
