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$
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I will implement iso 13485 and prepare your medical device company for certification
Maryam
Level 2
4.9
4.9
Gig Summary
About this gig
Achieve ISO 13485 certification with expert guidance tailored for medical device manufacturers, distributors, startups, and healthcare organizations.
I provide professional ISO 13485 consulting and certification preparation services to help your organization establish, implement, and improve its Quality Management System (QMS) in accordance with ISO 13485:2016 requirements.
Services include:
ISO 13485 Gap Analysis
Quality Management System (QMS) Development
Documentation Review and Preparation
Procedures, Forms, and Records Guidance
Internal Audit Support
CAPA and Risk Management Guidance
Management Review Preparation
Certification Audit Readiness Assessment
Stage 1 and Stage 2 Audit Preparation
Ongoing Compliance Support
Whether you are a startup developing your first medical device or an established manufacturer seeking certification, I will provide practical and cost-effective solutions based on your specific business needs.
Why choose me?
Extensive experience in medical device regulatory compliance
Expertise in ISO 13485, MDR, FDA QSR, and quality systems
Customized approach for each client
Professional and confidential service
Fast response and dedicated support
Thanks.
Get to know Maryam
Maryam
Certified Regulatory ISO and Compliance Expert for Medical and IT and Industries
Level 2
- FromUnited States
- Member sinceJul 2024
- Avg. response time1 hour
- Last delivery2 weeks
Languages
English
Global Regulatory, Quality, Cybersecurity & ISO Compliance Consultant specializing in Medical Devices, Digital Health & IT Security, supporting all industries worldwide. Expertise: EU MDR/IVDR, MDD to MDR CE, FDA, UKCA, SFDA, ISO 13485, 14971, 27001, 27017, 27018, 27701, 42001, 9001, 14001, 45001, 22000, 17025, 15189, 17024, 17100, 20000-1, 22301, 29993, 31000, SOC 2, HIPAA, GDPR, NIST, PCI DSS, GPSR, HACCP & GMP. Services include QMS/ISMS, technical documentation, risk management, gap assessments, audits, implementation, certification readiness, regulatory submissions & global market access.
My Portfolio
Other Regulatory Compliance Consulting Services I Offer
FAQ
Can you support EU MDR compliance?
Yes. I can help align your quality system with: EU MDR 2017/745 EN ISO 13485:2016+A11:2021 Technical documentation expectations
What services do you provide for ISO 13485?
I provide: ISO 13485 documentation Gap analysis SOP development Quality Manual creation Internal audit support CAPA procedures Risk management templates MDR compliance support Certification readiness assistance
Can you help medical device startups?
Yes. I support: Startups Small manufacturers Export companies Existing certified companies Contract manufacturers
Do you customize documents according to my company?
Yes. All documents are customized according to: Product type Company activities Sterile/non-sterile scope Manufacturing process Regulatory market requirements
Do you provide complete ISO 13485 documentation?
Yes. Depending on package scope, documentation may include: Quality Manual Procedures/SOPs Forms & records Risk management procedures Complaint handling Supplier controls Traceability procedures Internal audit templates CAPA procedures
Can you help prepare for ISO 13485 certification audits?
Yes. I provide: Audit readiness support Gap analysis Internal audit support Nonconformity guidance CAPA recommendations
Can you help with FDA QMSR alignment?
Yes. I can support quality system alignment with FDA QMSR principles linked to ISO 13485.
Do you offer urgent delivery?
Yes. Urgent delivery may be available depending on project scope and workload.
Is my company information confidential?
Yes. All documents and company information are treated confidentially.
Why should I choose your service?
My service focuses on: Customized professional documentation Practical implementation support Medical device industry experience MDR-oriented guidance Long-term compliance support Responsive communication
Reviews
51 reviews for this Gig
| (48) | ||
| (2) | ||
| (0) | ||
| (0) | ||
| (1) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
S s_p_d_orcaa
Australia
punctual, reviewing now.
$50
Price
3 days
Duration
Helpful?A awenckebach
Switzerland
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
$5,000-$10,000
Price
4 weeks
Duration
M 
Seller's Response
Helpful?A awenckebach
Switzerland
Fast and efficeint, in summary very good work. We are now engage Myryam on a more sustained work, and looking forward to the next phases of work.
$200-$400
Price
3 days
Duration
Helpful?M mary_gonzales1
United States
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
$50-$100
Price
2 days
Duration
Helpful?W willardadk
United States
The seller showed strong attention to detail and a clear understanding of the project objectives.
$50-$100
Price
1 day
Duration
Helpful?
Reviews
51 reviews for this Gig
| (48) | ||
| (2) | ||
| (0) | ||
| (0) | ||
| (1) |
Rating Breakdown
- Seller communication level
- Quality of delivery
- Value of delivery
Sort By
Most relevant
S s_p_d_orcaa
Australia
punctual, reviewing now.
$50
Price
3 days
Duration
Helpful?A awenckebach
Switzerland
Maryam reacted quite fast to address our gaps in the ISO 13485 process. Efficient
$5,000-$10,000
Price
4 weeks
Duration
M Seller's Response
Helpful?A awenckebach
Switzerland
Fast and efficeint, in summary very good work. We are now engage Myryam on a more sustained work, and looking forward to the next phases of work.
$200-$400
Price
3 days
Duration
Helpful?M mary_gonzales1
United States
Very satisfied with the service. The seller delivered a polished result and maintained a professional workflow throughout.
$50-$100
Price
2 days
Duration
Helpful?W willardadk
United States
The seller showed strong attention to detail and a clear understanding of the project objectives.
$50-$100
Price
1 day
Duration
Helpful?
