Question 1

What is ISO 13485:2016?

Accepted Answer

ISO 13485:2016 defines the quality‑management system requirements that organizations must meet to design, produce, install and service medical devices while consistently satisfying customer and regulatory demands.

Question 2

How many companies comply with ISO 13485:2016?

Accepted Answer

Based on our data, 26,055 companies comply with ISO 13485:2016. This number is updated daily as we discover new companies through job posting analysis.

Question 3

What types of companies comply with ISO 13485:2016?

Accepted Answer

ISO 13485:2016 is relevant across multiple industries including Research Services, Hospitals and Health Care, Medical Equipment Manufacturing. Companies range from startups to enterprises with 10,000+ employees.

Question 4

How does TheirStack track companies related to ISO 13485:2016?

Accepted Answer

TheirStack analyzes millions of job postings daily from company career pages, job boards, and recruitment platforms. When a company mentions ISO 13485:2016 in their job descriptions, requirements, or responsibilities, we identify them as related to ISO 13485:2016 and add them to our database.

Question 5

How can I get the full list of companies that comply with ISO 13485:2016?

Accepted Answer

You can access the complete list of 26,055 companies on TheirStack. The data includes company name, industry, size, location, funding, and revenue. Available via our web app or API.

Question 6

How often is the company data updated?

Accepted Answer

Our database is refreshed daily. We continuously monitor job postings to detect new companies complying with ISO 13485:2016 and update existing records.

Company	Country	Industry	Employees	Revenue	Technologies
Thermo Fisher Scientific	Switzerland	Research Services	130k	$44B	ISO 13485:2016
Johnson & Johnson	United States	Hospitals and Health Care	138k	$94B	ISO 13485:2016
Medtronic	United States	Medical Equipment Manufacturing	101k	$32B	ISO 13485:2016
Abbott	United States	Hospitals and Health Care	158k		ISO 13485:2016
Boston Scientific	United States	Medical Equipment Manufacturing	55k		ISO 13485:2016
Stryker	United States	Medical Equipment Manufacturing	52k	$18B	ISO 13485:2016
BD	United States	Medical Equipment Manufacturing	77k	$19B	ISO 13485:2016
Philips	Netherlands	Hospitals and Health Care	82k	$19B	ISO 13485:2016
Olympus Corporation	Japan	Hospitals and Health Care	14k		ISO 13485:2016
Fujifilm	United States	Medical Equipment Manufacturing	1.7k	$20B	ISO 13485:2016

Companies complying with ISO 13485:2016

List of companies that comply with ISO 13485:2016