OPERON ELEVATEPLUS | BIS CERTIFICATION
BIS Consultants for Medical Devices
As experienced BIS Consultants, Operon Strategist provides end-to-end BIS certification consulting for medical device manufacturers seeking compliance with the Bureau of Indian Standards (BIS). Our services include regulatory strategy, applicable Indian Standards (IS) identification, product testing coordination, technical documentation, factory inspection support, certification applications, and post-certification compliance. We help manufacturers reduce regulatory risks, streamline approvals, and achieve BIS certification for successful commercialization in the Indian market.
Take the next step
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
BIS Certification & Regulatory Compliance – We help medical device manufacturers obtain BIS certification through a structured compliance approach aligned with Bureau of Indian Standards (BIS) requirements and applicable Quality Control Orders (QCOs). Our services include product standard identification, testing coordination with BIS-recognized laboratories, technical documentation, factory inspection support, certification applications, and ongoing compliance management. We develop audit-ready documentation, reduce regulatory risks, and accelerate successful BIS certification for the Indian market.
Operon BIS Certificate Consulting Services Advantage
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
You Might Also Be Interested in
frequently asked questions
What do BIS Consultants do?
BIS Consultants guide manufacturers through the complete certification process, including applicable standard identification, documentation preparation, laboratory testing coordination, factory inspection support, regulatory submissions, and certification management.
Which products require BIS Certification?
The requirement depends on applicable Indian Standards and Quality Control Orders (QCOs). We assess your product and determine whether BIS certification is mandatory.
What is BIS Certification?
BIS Certification is a conformity assessment issued by the Bureau of Indian Standards (BIS) to ensure products comply with applicable Indian Standards (IS) and mandatory Quality Control Orders (QCOs), where applicable.
What is BIS certification for medical devices in India?
BIS certification demonstrates that a product complies with applicable Indian Standards established by the Bureau of Indian Standards, helping manufacturers demonstrate product quality, safety, and conformity with relevant requirements.