Why ISO 13485:2016 Is Not "Just an Option" for MedTech

The medical device sector is 100% patient-centric, trust-based, and globally healthcare-compliant. The manufacturing of medical equipment is very sensitive, as any minute defect could endanger public health. Getting ready for a different regulatory system is quite a difficult challenge for manufacturers, suppliers, and distributors who need to expand their businesses in competitive markets of the healthcare sector.

It is here that a globally recognized standard makes the connection between local production and access to the international market. ISO 13485:2016 is a new ISO standard that has been recently released.

Table of Contents
1.	What Does It Mean for Your Healthcare Business?
2.	Who Can Tell You the Benefits of Getting an ISO 13485 Certification? International Trade Aggressive Product Safety & Risk Isolation Deep Stakeholder and Procurement Trust Full Regulatory Alignment
3.	What is the Compliance Mechanism Central Drugs Standard Control Organization (CDSCO) Alignment Kuwait (MoH Registration)
4.	What Does It Take to Be Compliant? Explain the concept of Scope & GAP Analysis Document Control & Quality Manual Staff Training & Implementation Internal Auditing Assessment by a third party
5.	How is the Cost of ISO 13485 Certification Determined?
6.	Why Is AQC World the Best Place to Embark on Your Certification Journey?

What Does It Mean for Your Healthcare Business?

There isn't a better answer than ISO 13485:2016, the international standard for a Medical Device Quality Management System (MDQMS). It is ISO 13485:2016, which is issued by the International Organization for Standardization (MDQMS). There is a complete set of criteria specifically designed to aid organizations in safely producing, designing, installing, and servicing medical equipment.

This medical-specific standard, instead of just business performance, such as generic quality frameworks, emphasizes risk management, product safety, and strong compliance with regulations through all the phases of the product's life. The uptake of MDQMS is also rising worldwide, and the global market data shows that the number of active certificates has increased at an annual rate of 6% to 8%, reflecting the impetus to strengthen medical safety legislation by national health ministries.

Who Can Tell You the Benefits of Getting an ISO 13485 Certification?

The benefits that this comprehensive QMS brings to healthcare businesses aiming to establish long-term authority are apparent from the moment it's set in place.

• International Trade: It facilitates international trade across borders and provides a universal passport to export products without having to repeat the audits required at baseline.
• Aggressive Product Safety & Risk Isolation: The process helps manufacturers to proactively identify, detect, and isolate risks before products are made and they exit the facility, having a very aggressive risk timeline in mind. This can be directly linked to fewer product recalls and manufacturing errors.
• Deep Stakeholder and Procurement Trust: Government procurement offices and healthcare providers, and even international distributors, prefer and sometimes only accept working with certified production facilities.
• Full Regulatory Alignment: It aligns your processes with the major international statutory requirements such as the European Union MDR, US FDA, and the Gulf Health Council requirements.

What is the Compliance Mechanism?

Healthcare markets aren't the same around the world. The ISO 13485 for medical devices framework is adopted as a starting point for each target region, but each will do so within local regulatory frameworks:

Central Drugs Standard Control Organization (CDSCO) Alignment: In India, medical devices have been subject to stringent licensing regimes over the years and now cover a vast array of devices. An authentic quality system is strongly emphasised as a critical method by the auditors to demonstrate sustainable manufacturing hygiene and is a key factor in acquiring a manufacturing or import license under the MDR. To delve deeper into this, read our insights on the AQC Medical Industry Certification Overview, and discover how ISO 13485 helps to enable sustainable healthcare scaling in our breakdown of ISO 13485 for Enhanced Marketability.

At the UAE Ministry of Health and Prevention (MoHAP), it is a requirement that all medical supplies entering the UAE must be transparent. When the registration and clearance processes of a company are supported by a verified international certificate, then it is a lot easier to get registered and cleared from the official portals of the UAE free zones and mainland UAE.

Kuwait (MoH Registration): Kuwait has very strict guidelines set by its Ministry of Health (MoH), which demand that all information about device lifecycles and material sourcing be documented. Using a validated international standard as the basis for implementing reduces the bulk of Kuwait's technical file submissions significantly and shortens the time-to-market.

What Does It Take to Be Compliant?

Full compliance is a process of systematic steps on the Plan-Do-Check-Act (PDCA) continuous improvement cycle that a company must take.

1. Explain the concept of Scope & GAP Analysis:

Phase1.Create an all-encompassing organizational map and evaluate existing manufacturing processes in comparison to standard processes to determine missing controls.

2. Document Control & Quality Manual:

Phase 2. Establish and document protocols for risk reduction, tracking raw materials, maintaining sanitation records, and product life cycle management.

3. Staff Training & Implementation:

Phase 3. Provide education to your engineering, production, assembly, and other employees on compliance requirements and have clear hygiene guidelines and testing parameters implemented throughout the day.

4. Internal Auditing:

Phase 4. Get internal auditors to test your new systems, collect objective evidence, and correct any non-conformances before the formal evaluation.

5. Assessment by a third party:

Phase 5. Have a certified and independent registrar come to your facility, check records, and provide you with a certificate of compliance.

How is the Cost of ISO 13485 Certification Determined?

It is important to understand that there is no standard price for ISO 13485 certification cost, as it varies from one company to another. This depends on different operational aspects that your selected registrar considers in the initial application process:

The total number of working employees in all manufacturing lines.

The number, size and physical locations of your manufacturing facilities (including multiple locations).The complexity, sterilization requirements and risk level of the medical device being developed.

Consider working with an internationally recognized ISO 13485 certification body with respected accreditations (like UAF or EGAC) directly, rather than going through secondary brokers to optimize the use of your compliance budget, and also obtain your certificate with the global logo of the IAF.

Why Is AQC World the Best Place to Embark on Your Certification Journey?

The healthcare industry is complex, and it's difficult to navigate the intricacies of healthcare regulations without an expert and a trusted compliance partner who is well-versed in the latest regulations, both national and international. Assurance Quality Certifications LLC (AQC) is one of the top international registrars offering cost-effective ISO 13485 certification services that meet the criteria of UAF and EGAC to allow you to grow with confidence in India, UAE, and Kuwait. From gaining market share locally to going global, we have the expertise and detailed auditing to ensure that your systems are validated seamlessly.

Looking to change your quality infrastructure and open up highly regulated global healthcare networks? Get your team of lead auditors today by contacting us at +91 882 642 1234.

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