End-to-end certification and regulatory compliance for Indian and global markets.
BIS Certification
CDSCO
CPCB
LMPC
WPC Approval
Global Approvals
TEC
ARAI
BEE
ISO Certification
Drone Registration
NOC For Steel
Apart from product certification, BIS is responsible for framing Indian Standards, conducting laboratory testing, and ensuring consumer protection.
Some items must be certified before they get released mysteriously made for select goods like cables, switches, cement, gas cylinders, etc.
It ensures electronic products conform to Indian Standards (IS).Covers 70+ products including laptops, phones, adapters, TVs, and batteries.
Hallmarking Certification is mandatory in India for gold and silver jewellery.The BIS 916 Hallmark confirms 22K gold purity.Silver Hallmarking is compulsory for certain grades like BIS 925.
FMCS Mark Certification is a BIS-led approval process that enables foreign manufacturers to sell regulated products in the Indian market.
It helps manufacturers build trust and create a compliance framework. It also markets to eco-conscious consumers.This guide will detail eligibility, provide information on the application procedure, and outline benefits of certification to ISO 14024.
It is governed by NABL under the Quality Council of India (QCI).Accreditation enhances trust among regulators, industries, and global partners.
The World Manufacturer Identity (WMI) is a globally recognized code used to identify vehicle manufacturers. WMI registration ensures traceability, compliance, and global brand recognition for automotive makers.
Stay ahead of regulatory changes with BIS Scheme X Certification. Now extended to September 1, 2026, under the omnibus technical regulation order 2024. Get complete certification support from Diligence Certification.
Get full assistance for CDSCO registration, medical device import licenses, and cosmetic import licenses with Diligence Certifications. Our expert guidance and comprehensive support ensure your compliance, helping you gain a competitive edge in the market. Your satisfaction is our commitment!
Diligence Certifications is a top-tier name in drug licensing and provides topmost service and knowledge support to all sizes of pharmaceutical companies. Our seasoned team understands the global regulations and has seen several success stories.
Having trouble securing Cosmetic License certification in India? Let our ISI certification experts assist you in achieving it and boosting your credibility!
Get expert guidance on Medical Device Registration in India. Learn CDSCO approval process, documents, fees & compliance for manufacturers and importers.
Secure your CPCB Certification with ease and align your business with environmental regulations and sustainable practices. Our expert team streamlines the application process, offering tailored guidance to meet your unique EPR compliance requirements.
Need assistance in Battery Waste Certification? Our experts guide you through every step to ensure smooth and compliant processing.
E-waste has become one of the most serious problems of the modern world, as technology is changing very fast. Discarded electronics items such as smartphones and refrigerators contain very toxic elements hazardous to human health and the environment if not treated properly.
Tyre wastage is an increasing global problem. It threatens to engulf the world in a sea of rubber with disastrous consequences for the environment and human health.
Diligence Certifications help businesses go a long way in environmental compliance matters through their management of plastic waste compliance. It rallies your commitment to reducing environmental impacts, increasing your recycling, driving circular economies and, hence, building credibility with consumers as citizens of a wider world contending against plastic pollution with angels and regulators.
Having trouble in getting EPR registration for your oil products in India? Let the experts do it for you and give credence to your products!
The No-Objection Certificate has special relevance for a business; from needing it while applying for a loan, selling property, or for an application to pursue higher education, there are multiple situations where one has to face the need for an NOC.
Get Full Assistance for Model Approval for Indian W&M Instruments and Importer Registration for Weight and Measurement Instruments with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your LMPC Certification needs, helping you gain a competitive edge in the market. Your satisfaction is our commitment, and we work tirelessly to ensure it, now and in the future.
The Diligence Certifications for Packaged Commodities Certification ensures the product conformity with the regulatory requirements. It assesses your product labeling, weight, and quality for compliance with legal requirements and gives transparency and consumer trust. This certification is an instrument of defense against wrong packaging for business and consumers alike and shows your commitment toward fair trading practices and market integrity.
Diligence Certifications offers provision of LMPC Import License Certification under Legal Metrology Packaged Commodities rules with respect to process of importation of goods into India for compliance. Our proficiency ensures that your labeling and packaging for products meet the requirements for easy clearance of goods through customs. It certifies approval from the regulators, having legal backing and gaining confidence of consumers and authorities.
The legal metrology certification is gaining importance in today’s ever-changing context of business with emphasis on fair trade and consumer protection. There is a fresh perspective on maintaining the true measurement and weighing-related activities on account of the fact that with almost every passing day, market growth and transaction complications are assuming greater magnitude.
The company is authorized to undertake the LMPC Manufacturer Registration if it manufactures weights and measures within India. This registration under the Legal Metrology Act guarantees fair and correct transaction laws for business and trade activities through LMPC certificate registration. Let us demystify all the information you would require below.
Get Full Assistance for Non-Network License, Network License, and Equipment Type Approval with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your WPC Approval needs, helping you gain a competitive edge in the market. Your satisfaction is our commitment, and we work tirelessly to ensure it, now and in the future.
The Diligence Certifications grant a fast track to the acquisition of WPC Import License, making the imports of communication devices 100% compliant with WPC Certification. Based on our experience and expertise, we ready you for the licensing processes in such a way that your product conforms with all technical standards and is safely usable within India. The certification would guarantee acceptance by regulators, therefore cultivating such trust with the authorities and end users.
Today-connected world, indeed, keeps the promise of wireless devices. Today manufactured devices include laptops, smartphones, portable WiFi hotspots, WiFi extenders, and smart home appliances. However, with this pressing usage, there is a huge demand for safety and performance requirements.
In this hyper-connected age, wireless access points, portable Wi-Fi routers, and other radio frequency (RF) devices are indispensable. When any of these products are manufactured, imported, or sold in India, the knowledge of and acquiring Equipment Type Approval (ETA) becomes imperative; that’s how Diligence Certifications will help you obtain your WPC Certification more conveniently.
In today’s world with increasing environmental consciousness, it is vital to dispose of equipment properly after the intended lifetime. Targeting hazardous e-waste is one of the vital roles played by RoHS; elaborately explaining RoHS certification itself, RoHS objectives, substances involved, certification processes, and applicability in curbing environmental contamination.
Diligence Certifications provides UL (Underwriters Laboratories) Certification services to ensure your products comply with rigorous safety and performance standards. Our skilled team supports you throughout the certification process, ensuring full adherence to UL requirements. Achieving UL certification with us boosts your product’s credibility, fosters consumer confidence, and highlights your dedication to safety and quality in the market.
KC Certification is a major mandatory condition for many products that are developed to reach Korea’s genuine profitable consuming market. KC Certification is otherwise known as KC Registration or simply the Korean Certificate, and denotes compliance with Korean safety standards and regulations.
Struggling with FCC certification in India? Our expert team at Diligence Certifications can help you navigate the process effortlessly, ensuring your electronic devices meet all compliance standards. Boost your credibility and market access with FCC certification today!
Among these is the CE Marking, which is especially pertinent to manufacturers who are considering selling their products in the European Economic Area (EEA).
CB stands for Certification Bodies Scheme.An international system operated by IECEE (IEC System for Conformity Testing and Certification of Electrotechnical Equipment and Components).Facilitates mutual recognition of test results among participating countries.Enables global market access for electrical and electronic products.Reduces the need for multiple testing and certification in different countries.
The SAFTA certificate online enables reduced customs duties under the SAARC trade agreement.Businesses can apply for a SAFTA certificate digitally through authorised agencies in India.This document is vital for proving origin and unlocking tariff benefits.
You can apply online for your MSDS Certificate in India through many trusted compliance and safety services.This documentation allows the company to maintain regulatory safety and hazard management which also protects the world you operate in.
SALEEM / SABER system is the online conformity platform linking exporters, certification bodies, and customs.Two stages: Product CoC (PCoC, valid one year) and Shipment CoC (SCoC, per consignment).
It replaces the CE marking post-Brexit and is mandatory for most regulated products.Indian manufacturers exporting to the UK need UKCA marking to stay compliant.
Get Full Assistance for TEC Type Approval, TEC Interface Approval, TEC Certification Approval and TEC Approval of Technology with Diligence Certifications. We prioritize your success by providing expert guidance and comprehensive support for all your TEC Approval needs, helping you gain a competitive edge in the telecommunications market. Your satisfaction is our commitment, and we are dedicated to ensuring it now and in the future.
Get full assistance for ARAI Vehicle Certification for vehicles, engines, and components with Diligence Certifications. With over 25 years of experience, we prioritize your success in gaining a competitive edge in the automotive market. Trust our expert guidance for all your ARAI certification needs.
Having trouble securing BEE Star Rating Certification in India? Let our ISI certification experts assist you in achieving it and boosting your credibility!
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
It is critical to understand how to get ISO Certification for audit and compliance purposes.Read on to learn step-by-step how to get ISO certified in India with expert assistance.
Drones above nano size must be registered on Digital Sky and obtain a UIN, Type Certificate, remote-pilot certificate (for commercial use), and insurance—while adhering to airspace rules and NPNT protocol.
Importing steel into India? Get your No Objection Certificate (NOC) under the Steel Quality Control Order (QCO) without delays or compliance risks. Diligence Certifications offers complete support for steel importers—ensuring your products meet Ministry of Steel and BIS regulations, and helping you avoid customs issues, rejections, or penalties. Stay legally compliant, save time, and streamline your steel import process with our expert certification services.
End-to-end certification and regulatory compliance for Indian and global markets.
Business Registration
In addition, you will be briefed on how Limited Liability Incorporation protects you and how Diligence Certifications may assist one in navigating the certification process.
Diligence Certifications streamlines the One-Person Company (OPC Registration in India) registration process, ensuring compliance with all.
Starting a Limited Liability Partnership (LLP) can be a strategic move for entrepreneurs looking to combine the benefits of a partnership with the advantages of limited liability partnership.
Starting a business is an exciting venture, and choosing the right legal structure is a crucial first step. For many entrepreneurs, a partnership firm offers a flexible and collaborative way to operate.
Unlock the exclusive benefits and enhance the startup with Startup India Registration – along with that Diligence Certifications can help you with the whole process and ensure that every requirement is fulfilled for a successful Startup India Registration in India.
Are you really into making a difference or starting your own Non-Governmental Organization (NGO Registration) in India? We will also mention how Diligence Certifications can assist you in such cases.
The PESO License framework establishes mandatory approval processes for products relevant to the oil and gas sector, particularly those involved in gas handling or intended for use in corrosive environments prevalent in the industry.
Well, at this point, are you really ready to take it to the next level? The formation of Private Limited Company Registration in India is often considered to be a strategic alternative by most entrepreneurs since it provides credibility combined with a limited liability and a scope for future investments:
Our expert team provides comprehensive guidance through each step, from documentation to application submission. With our assistance, you can establish your subsidiary efficiently, gain legal recognition, and leverage opportunities for growth in the Indian market.
The Producer Company Registration offers this sort of power to farmers to organize and run businesses for their mutual benefit collectively.How Diligence Certifications can facilitate the process with credibility for a Farmer Producer Company (FPC).
It offers a straightforward setup and direct control, making it the most popular and straightforward business structure in India.
Setting up a new enterprise should be exciting, even though there are deterrents in legal implications. That is a journey almost every business-making entity undertakes, from the littlest to the largest-the Shop and Establishment Registration.
Our expert team provides comprehensive support throughout the registration process, from documentation to application submission. With our assistance, you can access government benefits, secure funding opportunities, and enhance your business credibility in the competitive market.
FSSAI mark certification is an important regulatory mechanism that guarantees strict adherence to food safety and quality standards by all food products manufactured, imported, and sold in India.
No longer complicated definitions for you; just straight, simple, useful information that will get your business going.
End-to-end certification and regulatory compliance for Indian and global markets.
Legal Services
Trademark Registration
Copyright Registration
Patent Registration
A Bengaluru-based startup developing diagnostic imaging systems encountered such significant hurdles last year, despite getting VC funding and a promising AI-based product, that they could not enter EU or US markets due to one single element. ISO 13485 certification. Investors wanted it, regulators wanted it, and hospitals would not engage without it. This story is not rare – in India’s fast-paced medtech sector, certification is not a box ticking exercise, it is survival.
ISO 13485 is more than a standard. It is a worldwide accepted benchmark for quality management systems (QMS) for medical device companies. Whether your company produces syringes, surgical instruments, or AI-enabled diagnostics, ISO 13485 certification provides a structure to demonstrate product safety, mitigate regulatory risk, and foster trust with stakeholders.
Let’s explore in depth why ISO 13485 is important, what the certification process involves, and how your organization can utilize it as a lever for growth and compliance.
ISO 13485 certification is an international standard that defines the requirements for a Quality Management System (QMS) for organizations involved in any stage of the life-cycle of a medical device.
It pertains to:
“ISO 13485 is not a product, it is a process assurance standard that reinforces your dedication to patient safety.”
ISO 13485 is not industry agnostic like ISO 9001, as ISO 13485 applies solely to the medical device industry. The latest version, ISO 13485 2016, is aligned with the older ISO 9001 2008 model. The reason for it to be rigid is to provide a consistent structure for a regulatory body.
With India’s medical device market estimated to touch USD 50 billion by 2030, a plethora of MSMEs face obstacles related to international expansion in large part through regulatory uncertainty. ISO 13485 is one such entry point to helping bridge this gap.
Key Drivers in the Indian Context:
Competitive and Operational Advantages:
The ISO 13485:2016 standard is structured into eight sections, with five focusing on mandatory QMS requirements:
1.Quality Management System
Establishes the documentation, procedures, and controls needed to produce quality products.
2.Management Responsibility
Management needs to demonstrate commitment, provide the needed resources, and foster an environment of continuing improvement.
3.Resource Management
Ensures competence of personnel, suitable facilities, and calibrated instruments.
4.Product Realisation
Covers the entire process from design to delivery of the medical device.
5.Measurement, Analysis and Improvement
Focuses on internal audits, corrective actions, and product traceability.
Organisational Requirements:
Technical Files:
Process-Specific Documents:
Non-Conformance Reports
A few years ago, a mid-sized medical device manufacturing company in Gujarat, India—let’s call them MedEquip Solutions—was facing frequent operational slowdowns, unexpected product recalls, and delays in product approvals. Despite their best efforts, something always seemed to go off track—documents missing, procedures misunderstood, and inconsistent product quality.
Their turning point came when a major European distributor refused to onboard their products, citing non-compliance with ISO 13485. That was their wake-up call.
The ISO 13485 Analogy in Action:
When it comes to medical device manufacturing, compliance is not optional—it’s life-critical. That’s why choosing the right partner for ISO 13485 certification can make all the difference.
Expertise You Can Count On
Our team understands the unique challenges of ISO 13485, from risk management to regulatory requirements. We don’t just offer templates—we offer tailored solutions that work for your business model.
End-to-End Certification Support
From documentation to internal audits and final certification, we guide you through every step of the ISO 13485 journey. No guesswork. No wasted time.
Global Compliance, Local Insight
Whether you’re targeting CE, FDA, or other international markets, we ensure your quality system aligns with global expectations, while respecting Indian regulatory needs.
Faster Certification. Smoother Inspections.
Our clients often achieve certification faster and experience fewer non-conformities during audits—all thanks to our proactive readiness approach.
Proven Track Record
From startups to established manufacturers, we’ve helped dozens of clients get ISO 13485 certified and confidently enter domestic and global markets.
Clear Communication & Honest Guidance
No jargon. No overpromises. Just transparent advice and practical implementation strategies that save you time and money.
In an industry in which lives depend on reliability, ISO 13485 certification isa business necessity, not just a regulatory requirement. From opening doors and building trust, to reducing risk, ISO 13485 certification is strategically important to Indian medical device manufacturers going global.
Regardless of whether you are a small startup or a large enterprise, investing in ISO 13485 standards helps demonstrate that your products can be both innovative while still being safe, compliant, and competitive globally.
Are you ready to start? Let diligence certifications help make your ISO certification process seamless.
ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for the medical device industry.
Manufacturers, distributors, and service providers that are involved in any of the lifecycle activities of a medical device.
It is not mandatory for everyone, but it is required for CDSCO Registration and to export to regulated markets.
3 years, with annual surveillance audits.
It depends on company size, complexity, and certifying body, but it can be about INR 75,000 to several lakhs.
It usually takes about 3 to 6 months but depends on the level of documentation you have and how and readiness.
The latest version is ISO 13485:2016. There are no updates as of 2025.
Yes, if they are specifically seeking to enter the international market.
Third-party accreditation bodies such as TUV, BSI, DNV, or SGS.
Yes, it's routinely incorporated with ISO 9001, ISO 14971, and ISO 27001.
ISO 9001 is a generic standard, while ISO 13485 is tailored for medical devices with a regulatory emphasis.
Yes, the EU is aligned with the MDR; the US FDA makes use of 21 CFR Part 820, but will generally accept ISO 13485.
Market access loss, regulatory non-compliance, legal penalties, and product recalls.
At least annually or as risk benchmarking internally espouses a need for frequency.
Yes, if it is shown through surveillance audits that the organisation is not compliant.
