qualityworks.

qualityworks.

Medical-Equipment-Manufacturing

Company Tagline

Medical device quality and regulatory services you can count on

Industry Category
Medical-Equipment-Manufacturing
Company Description

Qualityworks is a leading provider in the Medical Equipment Manufacturing industry, dedicated to offering comprehensive medical device quality and regulatory services. With over 17 years of proven experience, Qualityworks delivers customized quality assurance and regulatory affairs consulting services tailored to meet specific needs. The company provides a comprehensive approach to the medical device market, equipping clients with the essential tools, guidance, and support necessary for success.

Qualityworks specializes in several key areas including Regulatory Affairs, Medical Device compliance, CFR 21 PART 820, ISO 13485, MDSAP, CE Marking, and Quality Assurance. Operating from its primary address in Petah Tikva, IL, Qualityworks is committed to ensuring the highest standards in medical device quality and regulatory adherence. The services are designed to navigate the complexities of the medical device landscape, fostering innovation and compliance.

Qualityworks continually enhances its service offerings to stay ahead of industry trends and regulatory changes. Information will be completed soon with the support of the company’s management. We invite the manager of Qualityworks to create a customized and exclusive company showcase and product listing on our platform to further highlight the company’s expertise and capabilities.

Key Personnel / Employees
Sharon Resnick 🎗️

Compare Companies Side by Side

Compare qualityworks. with 3 companies in Medical-Equipment-Manufacturing

4 Companies
Comparison Field
qualityworks.
qualityworks.
Main Company
LDP Consulting
LDP Consulting
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Fang Consulting
Fang Consulting
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The Tao of Excellence
The Tao of Excellenc...
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Founded Year
1999 2015
Company Size
11-50 11-50 2-10
City
Roseville, MN Schaffhausen, Schaffhausen
Country
United States Switzerland
Skills & Keywords Comparing with main company
9 Total Skills
Medical Device Manufacturing Regulatory Affairs Quality Assurance ISO 13485 MDSAP CE Marking Medical Device Compliance Medical Device CFR 21 PART 820
9 Total 9 Unique
Unique Skills:
Clinical Affairs Clinical trials FDA submission Internal Audits ISO 14155 IVDR 2017/746 +3
15 Total 15 Unique
Unique Skills:
21 CFR 510(k) CE Mark Class I Design Dossier Preparation FDA +9
22 Total 22 Unique
Unique Skills:
Audit preparation Certification CH-REP Continuous Improvement Data Analysis Gap Analysis +16
4
Total Companies
1999
Oldest Founded
2
Countries
54
Unique Skills

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Alternative Company Names

This company is also known as

qualityworks. 优质作品 गुणवत्ता कार्य أعمال ذات جودة. качественные работы.