Medical device quality and regulatory services you can count on
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.
Compare qualityworks. with 3 companies in Medical-Equipment-Manufacturing
| Comparison Field |
qualityworks.Main Company |
LDP ConsultingView Profile |
Fang ConsultingView Profile |
The Tao of Excellenc...View Profile |
|---|---|---|---|---|
|
Founded Year
|
— | 1999 | 2015 | |
|
Company Size
|
— | 11-50 | 11-50 | 2-10 |
|
City
|
Roseville, MN | Schaffhausen, Schaffhausen | ||
|
Country
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United States | Switzerland | ||
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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
|
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