OPERON ELEVATEPLUS | BIS CERTIFICATE CONSULTING SERVICES IN INDIA
BIS Consultants for Medical Device Certification & Compliance
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Operon ElevatePlus
BIS Certificate Consulting Services in India Service Portfolio
BIS Applicability Assessment & Regulatory Strategy
Product scope evaluation under BIS regulations
Identification of applicable Indian Standards (IS)
Certification pathway selection (CRS / ISI / Scheme-I)
BIS CRS (Compulsory Registration Scheme) Certification
Eligibility assessment under CRS scheme
Coordination with BIS-recognized testing laboratories
Test report review and gap closure
Online CRS application submission and tracking
ISI Mark Certification (Scheme-I)
Factory evaluation and readiness assessment
Assistance with quality control documentation
Coordination for BIS factory inspection
Support through license grant and marking approval
Technical Documentation & Application Support
Compilation of BIS application dossier
Product specifications, test reports, and declarations
Online submission through BIS portal
Query handling and clarification support
Liaison, Audit & Inspection Support
Coordination with BIS officials and testing labs
Support during factory inspections and audits
Response to non-conformities and observations
Post-Certification Compliance & Renewal
License validity monitoring and renewal support
Product modifications and amendment assistance
Ongoing compliance advisorya
What Sets Us Apart
Global exposure, structured thinking, and execution-ready expertise
200+ Regulatory Certifications Supported Across India
Strong Experience with BIS CRS, ISI Marking & Scheme-I Certifications
Expertise Across Medical Devices, Electronics, Electrical & Consumer Products
Global Clients Supported for India Market Entry
Operon BIS Certificate Consulting Services Advantage
Expert guidance, streamlined certification, and end-to-end support for faster BIS compliance
End-to-End BIS Certification Lifecycle Management
Strong Coordination with BIS-Recognized Labs
Expert Handling of Documentation & Compliance Queries
Proven Track Record for Faster Approvals
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frequently asked questions
What do BIS consultants do?
BIS consultants help manufacturers understand applicable BIS requirements, identify relevant Indian Standards, prepare technical documentation, coordinate testing, support certification applications, and maintain ongoing compliance.
Is BIS certification mandatory for medical devices in India?
BIS certification requirements depend on the medical device type, applicable Quality Control Orders (QCOs), Indian Standards, and current regulatory requirements. Manufacturers should verify whether BIS certification applies to their specific product before entering the Indian market.
How do BIS consultants help medical device manufacturers?
BIS consultants support manufacturers by assessing product requirements, identifying applicable standards, reviewing compliance gaps, preparing documentation, coordinating testing, and guiding the certification process.
What documents are required for BIS certification?
The required documents depend on the product and certification scheme. Common documentation may include product specifications, manufacturing details, quality-control procedures, test reports, quality management system records, product labelling, and applicable application documents.
How long does BIS certification take?
The BIS certification timeline depends on the product category, applicable certification scheme, documentation readiness, testing requirements, factory inspection requirements, and the time required to address regulatory queries.
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