Global Certificate in ISO 13485 for Device Manufacturers

-- viewing now

The Global Certificate in ISO 13485 for Device Manufacturers is a comprehensive course designed to empower professionals in the medical device industry. This certification focuses on ISO 13485, an internationally recognized standard for quality management systems specific to medical devices.

4.0
Based on 3,057 reviews

7,962+

Students enrolled

GBP £ 140

GBP £ 202

Save 44% with our special offer

Start Now

About this course

It emphasizes the importance of establishing and maintaining a robust quality management system to ensure consistency and compliance in medical device manufacturing. In today's competitive landscape, there's an increasing demand for professionals who can demonstrate mastery of ISO 13485. This course equips learners with essential skills to meet this industry need, providing a solid understanding of the standard's requirements and practical knowledge on how to implement it effectively. By earning this certification, learners enhance their career prospects, demonstrate commitment to quality, and gain a competitive edge in the global medical device market.

100% online

Learn from anywhere

Shareable certificate

Add to your LinkedIn profile

2 months to complete

at 2-3 hours a week

Start anytime

No waiting period

Course Details

• Introduction to ISO 13485 & Medical Device Quality Management Systems
• Understanding Regulatory Requirements for Medical Device Manufacturing
• Key Principles & Clauses of ISO 13485:2016
• Implementing & Managing Quality Processes in Medical Device Manufacturing
• Risk Management in Medical Device Manufacturing: ISO 14971 Integration
• Documentation Control & Record Keeping in ISO 13485
• Internal Audits & Management Review for Continuous Improvement
• Corrective & Preventive Action (CAPA) in Medical Device Manufacturing
• Training & Competence in ISO 13485 for Device Manufacturers

Career Path

The Global Certificate in ISO 13485 for Device Manufacturers is becoming increasingly popular in the UK, with a growing demand for professionals skilled in this area. This 3D pie chart represents the latest job market trends for professionals with this certification. As a QA Engineer with an ISO 13485 certification, you can expect to be in high demand, with 40% of the market share. Your expertise in quality assurance will be highly valued, as you help ensure that medical devices meet the necessary regulatory requirements. Regulatory Affairs Specialists with an ISO 13485 certification hold 30% of the market share. In this role, you'll work closely with regulatory agencies to ensure that medical devices are compliant with all relevant regulations and standards. Medical Device Manufacturing Managers with an ISO 13485 certification account for 20% of the market share. With this certification, you'll be able to effectively manage the production of medical devices in compliance with ISO 13485 standards. Lastly, ISO 13485 Consultants make up the remaining 10% of the market share. As a consultant, you'll work with organizations to help them implement and maintain ISO 13485 standards, ensuring that they meet the necessary regulatory requirements. Overall, the Global Certificate in ISO 13485 for Device Manufacturers is a valuable certification that can open up many career opportunities in the medical device manufacturing industry in the UK.

Entry Requirements

  • Basic understanding of the subject matter
  • Proficiency in English language
  • Computer and internet access
  • Basic computer skills
  • Dedication to complete the course

No prior formal qualifications required. Course designed for accessibility.

Course Status

This course provides practical knowledge and skills for professional development. It is:

  • Not accredited by a recognized body
  • Not regulated by an authorized institution
  • Complementary to formal qualifications

You'll receive a certificate of completion upon successfully finishing the course.

Why people choose us for their career

Loading reviews...

Frequently Asked Questions

What makes this course unique compared to others?

How long does it take to complete the course?

What support will I receive during the course?

Is the certificate recognized internationally?

What career opportunities will this course open up?

When can I start the course?

What is the course format and learning approach?

Course fee

MOST POPULAR
Fast Track: GBP £140
Complete in 1 month
Accelerated Learning Path
  • 3-4 hours per week
  • Early certificate delivery
  • Open enrollment - start anytime
Start Now
Standard Mode: GBP £90
Complete in 2 months
Flexible Learning Pace
  • 2-3 hours per week
  • Regular certificate delivery
  • Open enrollment - start anytime
Start Now
What's included in both plans:
  • Full course access
  • Digital certificate
  • Course materials
All-Inclusive Pricing • No hidden fees or additional costs

Get course information

We'll send you detailed course information

Pay as a company

Request an invoice for your company to pay for this course.

Pay by Invoice

Earn a career certificate

Sample Certificate Background
GLOBAL CERTIFICATE IN ISO 13485 FOR DEVICE MANUFACTURERS
is awarded to
Learner Name
who has completed a programme at
London School of International Business (LSIB)
Awarded on
05 May 2025
Blockchain Id: s-1-a-2-m-3-p-4-l-5-e
Add this credential to your LinkedIn profile, resume, or CV. Share it on social media and in your performance review.
SSB Logo

4.8
New Enrollment