ISO 13485:2016 Certification, QMS Implementation & Audit Support for Medical Device Companies Across PAN India by Ikon Consultancy Services
Ikon Consultancy Services is a trusted ISO 13485:2016 certification consultant in Mumbai, helping medical device companies across Thane, Navi Mumbai, Panvel, Raigad, and across India achieve compliance with international quality and regulatory requirements.
With hands-on experience in the medical device industry, we support organizations at every stage, from documentation and implementation to certification audits and post-certification support.
ISO 13485 Consultancy Services in Mumbai, India
ISO 13485 is a specialized quality management standard designed specifically for the medical device sector. Unlike generic ISO standards, ISO 13485 focuses strongly on regulatory compliance, risk management, and patient safety.
At Ikon Consultancy Services, we work closely with:
- Medical device manufacturers
- Importers & exporters
- Distributors & traders
- Contract manufacturers
- Service providers supporting medical devices
Our ISO 13485 consultants in Mumbai follow a practical, audit-ready approach that helps organizations achieve certification smoothly and on time.
What is ISO 13485:2016 Certification?
ISO 13485:2016 is an international standard that specifies requirements for a quality management system (QMS) where an organization must demonstrate its ability to consistently provide medical devices and related services that meet:
- Customer requirements
- Applicable regulatory requirements
- Risk management and safety expectations
The standard applies to organizations involved in design & development, manufacturing, storage, distribution, installation, servicing, and related activities such as technical support.
ISO 13485 certification is applicable regardless of company size and is widely accepted across global markets.
Who Needs ISO 13485 Certification in India?
ISO 13485 certification is highly recommended and often expected for:
- Medical device manufacturers
- Importers & exporters of medical devices
- Medical device distributors and suppliers
- Sterilization and calibration service providers
- Testing labs and contract manufacturing units
- Companies supplying components used in medical devices
If you are dealing with CDSCO registration, tenders, exports, or OEM partnerships, ISO 13485 certification adds strong credibility.
Why ISO 13485:2016 is Important for Medical Device Companies
Medical devices directly impact patient health and safety. ISO 13485 helps organizations:
- Maintain consistent product quality
- Reduce risks associated with device failure
- Meet Indian and international regulatory requirements
- Build confidence with regulators, customers, and partners
The standard ensures that outsourced or externally provided processes are also controlled and monitored under your quality management system.
Benefits of ISO 13485:2016 Certification
- Improved compliance with medical device regulations
- Enhanced product quality and patient safety
- Reduced risk of recalls and non-conformities
- Easier approval for domestic and international markets
- Increased trust from hospitals, regulators, and clients
- Strong foundation for business growth and exports
ISO 13485:2016 Certification Process – Step by Step
Our ISO 13485:2016 certification process is designed to ensure regulatory compliance while minimizing disruption to your day-to-day medical device operations.
The process begins with an initial gap analysis, where our ISO 13485 consultants review your existing quality management system, procedures, and regulatory controls against ISO 13485:2016 requirements. This helps identify gaps and define a clear implementation roadmap.
Next, we support documentation development and system implementation. This includes preparing the quality manual, standard operating procedures, formats, and records aligned with your actual processes, regulatory obligations, and medical device lifecycle activities.
ISO 13485 awareness and implementation training is then conducted to ensure management and employees understand their roles, compliance responsibilities, and audit expectations. Proper training ensures effective implementation of the quality management system across departments.
Once the system is implemented, an internal audit is carried out to evaluate effectiveness and identify non-conformities or improvement areas. We also assist in conducting the management review meeting to ensure top management involvement and decision-making.
Before certification, a pre-assessment and readiness check is performed to confirm compliance with ISO 13485 requirements. We then provide full support during the Stage 1 and Stage 2 certification audits, coordinating with accredited certification bodies and assisting in closing audit findings.
Upon successful audit completion, the ISO 13485:2016 certificate is issued. Post-certification, we continue to support organizations through surveillance audits and continual improvement to maintain long-term compliance and regulatory readiness.
ISO 13485 Documentation & Implementation Support
We assist with complete ISO 13485 documentation, including:
- Quality Manual
- SOPs and work instructions
- Risk management files
- Control of documents & records
- System implementation support
- Supplier evaluation procedures
- Complaint handling and corrective action systems
Our documentation is simple, practical, and audit-friendly, not just theoretical templates.
ISO 13485 Consultants in Mumbai, Thane, Navi Mumbai, Panvel & Raigad
Ikon Consultancy Services provides local ISO 13485 consulting support to medical device companies located in:
- Mumbai
- Thane industrial areas
- Navi Mumbai MIDC zones
- Panvel manufacturing clusters
- Raigad industrial belts
Our consultants offer on-site and remote support, depending on client requirements.
ISO 13485 Certification Cost in Mumbai
The cost of ISO 13485 certification depends on factors such as:
- Organization size
- Scope of activities
- Number of processes and locations
- Level of existing documentation
We offer transparent and affordable pricing tailored to your business needs.
Why Choose Ikon Consultancy Services for ISO 13485 Certification?
- Experienced ISO 13485 consultants in Mumbai
- End-to-end support from documentation to certification
- Strong understanding of medical device regulations
- Fast and structured implementation approach
- Support during certification audits
- Post-certification and renewal assistance
We focus on practical compliance, not just certification.
FAQs – ISO 13485:2016 Certification
Is ISO 13485 mandatory in India?
ISO 13485 is not legally mandatory but is highly recommended and often required for regulatory approvals and tenders.
How long does ISO 13485 certification take?
Typically 2–4 months, depending on company size and readiness.
How long does ISO 13485 certification take?
Typically 2–4 months, depending on company size and readiness.
Can small medical device companies get ISO 13485 certified?
Yes. ISO 13485 applies to organizations of all sizes.
Is ISO 13485 required for exports?
Most international buyers and regulators expect ISO 13485 certification.
Contact ISO 13485:2016 Consultants in Mumbai
Looking for reliable ISO 13485 consultants in Mumbai, Thane, Navi Mumbai, Panvel, or Raigad?