You will get professional ISO 13485 QMS Standard Operating Procedure (SOP)
Project details
Establish a compliant Quality Management System with expert-drafted documentation for ISO 13485:2016 and FDA 21 CFR 820.
What I offer for $50:
I will draft one professional, audit-ready Standard Operating Procedure (SOP) or perform a Gap Analysis on an existing document.
Core areas covered:
-Risk Management (ISO 14971)
-CAPA & Complaint Handling
-Design Controls & Document Control
-Management Review & Internal Auditing
Why choose this project?
As a MedTech regulatory expert, I ensure your QMS documentation is not just compliant, but practical for your team. I specialize in MDD to MDR transitions and FDA QMSR alignment, delivering high-quality drafts in just 24 hours.
Get your quality system audit-ready today with precision and speed.
What I offer for $50:
I will draft one professional, audit-ready Standard Operating Procedure (SOP) or perform a Gap Analysis on an existing document.
Core areas covered:
-Risk Management (ISO 14971)
-CAPA & Complaint Handling
-Design Controls & Document Control
-Management Review & Internal Auditing
Why choose this project?
As a MedTech regulatory expert, I ensure your QMS documentation is not just compliant, but practical for your team. I specialize in MDD to MDR transitions and FDA QMSR alignment, delivering high-quality drafts in just 24 hours.
Get your quality system audit-ready today with precision and speed.
Document Type
ProcedureTopic
Biotechnology, Engineering, Manufacturing, Medical, TechnologyLanguage
English, German, GreekWhat's included $50
These options are included with the project scope.
$50
- Delivery Time 1 day
- Number of Revisions 1
- Number of Words 1500
- Number of Technical Illustrations 0
- Consultation
- Proofreading & Editing
- Additional Research
- References & Citations
- Formatted Style Guide
Frequently asked questions
About Zakir
Regulatory Strategy Expert | EU MDR & FDA QMSR | Accelerating MedTech
Montreal, Canada - 1:34 am local time
In 2026, compliance is your greatest competitive advantage. I help MedTech startups and global manufacturers navigate EU MDR (2017/745) and the new FDA QMSR to achieve market clearance with zero friction.
What I Help Clients With
- EU Regulatory Support (EU MDR / IVDR)
- Technical Documentation / Technical File preparation
- Clinical Evaluation Reports (CER)
- Performance Evaluation Reports (PER)
- Summary of Safety and Clinical Performance (SSCP)
- Post-Market Surveillance (PMS)
- Post-Market Clinical Follow-Up (PMCF)
- UDI implementation support
- EUDAMED readiness and registration guidance
US FDA Regulatory Support
- 510(k) submission support
- De Novo regulatory pathway support
- FDA QMSR transition alignment with ISO 13485
- Pre-Submission (Q-Sub) strategic support
- Regulatory gap assessments
- Submission planning and documentation support
Quality & Risk Management
- ISO 13485:2016 Quality Management System implementation
- ISO 14971:2019 Risk Management
- Risk files, hazard analysis, and FMEA
- Design controls and DHF support
- IEC 62366-1 usability engineering support
- Audit and inspection readiness
I help transform fragmented or legacy documentation into clear, structured, review-ready files that reduce regulatory back-and-forth.
Ready to secure your CE Mark or FDA Clearance? Let’s talk.
Steps for completing your project
After purchasing the project, send requirements so Zakir can start the project.
Delivery time starts when Zakir receives requirements from you.
Zakir works on your project following the steps below.
Revisions may occur after the delivery date.
QMS Gap Analysis & Scope
I will review your requirements and ensure the SOP aligns with ISO 13485:2016 and/or FDA 21 CFR 820 standards.
Drafting & Regulatory Alignment
I will draft the full SOP, including purpose, scope, responsibilities, and procedure steps, ensuring all regulatory citations are accurate.