Quality manual
Prepared, reviewed and organised for your iso 13485 certification engagement.
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ISO 13485 Certification
Quality systems for medical-device organisations.
Expert-ledregulatory support.
Starting price₹27999
Service modeOnline & Offline
Typical duration8–16 weeks
CoveragePan India
The service
Professional support,
Professional support,
clearly explained.
AuthorityAccredited ISO certification body
EligibilityImplemented medical-device quality management system
ValidityTypically maintained through surveillance and recertification audits
The License Sathi Promise
We believe in applicability first. Our compliance specialists run pre-checks on your documents and premises layout drawings before filing with the authority. This reduces rejection rates by over 80%.
Need custom assistance?
- hello@licensesathi.in
- Average response: 1 business day
- All states and Union Territories covered
Implementation and certification-readiness support for an ISO 13485 quality management system suited to your device operations.
What's included
- Process gap assessment
- QMS documentation
- Training and implementation
- Internal audit support
Typical documents required
- Quality manual and process map
- Risk management and design controls
- Supplier and production controls
- CAPA, complaints and post-market records
- Internal audit and management review evidence
Requirements can vary by state, device class, business structure and authority queries. We confirm the final checklist after an applicability review.
What you receiveA clearer path from
A clearer path from
requirements to readiness.
The engagement is structured around usable outputs—not vague advice—so your team can see what has been reviewed, prepared and submitted.
Required procedures
Prepared, reviewed and organised for your iso 13485 certification engagement.
Audit records
Prepared, reviewed and organised for your iso 13485 certification engagement.
Certification readiness report
Prepared, reviewed and organised for your iso 13485 certification engagement.
Your service journeyEvery stage has a
Every stage has a
defined next step.
You receive a practical view of progress from the first applicability check through filing and authority follow-up.
Applicability review
We confirm how ISO 13485 Certification applies to your organisation, location and intended activities.
Gap and document review
Your available records are checked against the authority checklist and practical readiness requirements.
Preparation and filing
Forms, declarations and supporting evidence are organised into a submission-ready application.
Tracking and resolution
We track progress, coordinate clarifications and help close authority observations through the decision stage.
“A strong application is not just a collection of documents. It is a consistent evidence trail showing that the people, premises, processes and controls meet the applicable requirement.”
License Sathi Compliance DeskPractical, document-led regulatory support
Common questionsBefore you
Before you
get started.
Clear answers to the questions clients usually ask before beginning ISO 13485 Certification.
Who should apply for ISO 13485 Certification?+
Implemented medical-device quality management system. We confirm exact applicability during the initial review.
How long does the process usually take?+
A typical engagement is planned for 8–16 weeks. Actual authority timelines can vary based on location, application completeness, inspection scheduling and queries.
Can License Sathi guarantee approval?+
No consultant can ethically guarantee a government or certification decision. We improve readiness, accuracy and response quality while the competent authority retains final discretion.
Will I receive a final document checklist?+
Yes. After the applicability review, we provide a requirement-specific checklist and identify missing, expiring or inconsistent records before filing.