How can Medical Device Makers in India Get ISO 13485 Certification?

India’s ISO 13485 certification for medical device makers specifies the standards for quality management systems (QMS). This certification is a global standard that sets the criteria for businesses that design, build, install, and maintain medical equipment. This accreditation may show that medical device companies are dedicated to safety, quality, and obeying the regulations all at once. You would need to be ISO 13485 certified to get CDSCO registration in India. This accreditation gives consumers and healthcare experts from all around the globe greater confidence.

What does it mean to be ISO 13485 Certified?

People all throughout the world know about and utilise ISO 13485. The International Organisation for Standardisation (ISO) is in charge of making it public. It stresses the need of building up and keep a Quality Management System (QMS) in place while making medical equipment. The standard was made to make sure that every stage, from design to delivery, meets international requirements for safety, performance, and traceability.

Why do Indian medical device firms need to achieve ISO 13485 certification?

ISO 13485 accreditation helps Indian medical device companies get business throughout the globe and makes sure they follow the laws.

Here are some important reasons why it is important:

What Documents Do You Need for ISO 13485 Certification?

• Certificate of Business Registration GST Certificate Chart of the Organisation
• Manual of Quality
• Standard Operating Procedures (SOPs)
• Instructions for Work
• Specifications for the product
• Reports on Risk Management
• Records of Process Validation
• Reports on the Calibration of Equipment
• Records of Customer Complaints
• Records of Corrective and Preventive Action (CAPA)
• Reports from internal audits
• Records of training, audit schedules, and evaluations of suppliers
• Files for design and development
• Records for Document Control Management Review Meeting Documents
• Managing Products That Don’t Meet Standards Traceability Records for Records
• Records of purchases and vendors

How to Get ISO 13485 Certification in India?

This is the step-by-step guide that medical device makers need to follow:

Step 1: Look for gaps

• Look at your present system and see how it stacks up against the criteria of ISO 13485.
• Find places where procedures, documents, or training are absent.

Step 2: Make a Quality Management System (QMS)

• Make a new Quality Manual or change the one you already have.
• Set rules for design, manufacturing, managing risk, keeping track of things, and getting input from customers.
• Make sure that every action is written down.

Step 3: Putting the QMS into action

• Use the stated processes in all departments.
• Teach workers about quality goals, paperwork, and how to regulate processes.
• Keep good records for each action.

Step 4: An internal audit

• Check how well your QMS works by doing internal audits.
• Find problems and fix them before the outside audit.

Step 5: Review by Management

• Hold a formal meeting with upper management to look at how well the QMS is working.
• Look at the audit results, the steps taken to fix problems, and the changes made to the process.

Step 6: Audit for Certification

There are usually two parts to the certification process:

Step 7: Surveillance Audits

• The certifying body conducts annual surveillance audits to ensure continued compliance.
• Non-conformities, if found, must be corrected within the given timeframe.

Validity of ISO 13485 Certification

Difference Between ISO 9001 and ISO 13485

Advantages of ISO 13485 Certification for Companies that Make Medical Devices

• Makes you more credible and accepted across the world
• Makes ensuring that CDSCO, EU MDR, and US FDA criteria are followed
• Lessens mistakes at work and makes things go more smoothly
• Makes it easier to keep track of products and documents
• Increases client trust and satisfaction
• Gives businesses more chances to grow in both home and international markets

How can ELT Corporate help you get ISO 13485 certification?

We help medical device makers in India get their ISO 13485 certification quickly and easily at ELT Corporate.

Our group of professionals can assist with:

• Documentation and gap analysis
• Making and putting into place a QMS
• Preparing for internal audits and management reviews
• Working together with ISO certification organisations
• Support for compliance after certification

ELT Corporate has been helping companies with medical device regulations for many years, so you can be confident that your company satisfies international quality requirements.