SW Industries AZ
SW industries is a leading supplier of products and services to the Dental and Healthcare communities. We provide turn key products and solutions as well as design, engineering , and regulatory consulting services.
SW Industries produces and distributes its Vantage line of Dental composite and restorative materials including:
Vantage PC composite
Vantage PC nano
Vantage PC Flow
Vantage I impression material
Sw Industries also produces custom dental laser and whitening equipment (devices)
Vantage-Pro STM Laser System with composite curing feature
Vantage –Pro in – office whitening system
Regulatory Consulting Services
Creative Compliance Associates (CCA), a subsidiary of SW Industries, provides support to medical device companies for compliance, remediation, and regulatory matters. We provide assistance with U.S., Canadian, European, and other international regulations. Specialties include preparing 510(k)s, product safety support to IEC 60601-1 series of standards, Quality Systems, CE Mark, FDA, Canadian Medical Device Regulations (CMDR). For further details please see our complete list of services. We have more than 20 years of experience working with the FDA and international regulatory agencies. We look for creative and expedient solutions for regulatory requirements and issues while meeting your business needs.
We provide the following services and support:
• Preparation of 510(k)s
• Response and remediation for FDA 483 (Warning letters)
• Assist with PMA & IDE submissions
• Assist with preparation and assessment of Technical Files and Design Dossiers for European Directives and Canadian Medical Device Requirements (CMDR).
Creation of Device Master Record (DMR) and Design History Files (DHF)
• Assist in preparation of EU and/or CMDR Essential Requirement checklists, and Risk Analysis per ISO 4971
• Assist in the preparation of Clinical Literature Evaluations. Evaluation of Clinical Data per MEDDEV 2.7.1 to meet the requirements of the MDD/AIMDD
• Review of product literature/packaging/labeling to MDD, AIMDD, CMDR, FDA, and IEC 60601 series (including general, collateral, and particular standards within the series) requirements
• Set-up your company’s standards and regulations list
• Set-up Quality Systems, FDA, cGMP, MDD, and CMDR procedures for your company
• Pre-Audit your company to ISO 9000:2015, ISO 13485:2016, QSR, MDD (EU CE Mark) and CMDR
• Perform Software Verification and Validation Protocols and Reports
• Assist with your Usability Engineering Process per IEC 62366 & IEC 60601-1-6
• Assist with your Risk Analysis, Risk Management, and Software Risk Analysis per ISO 14971
• Act as your Compliance Engineer on an as-needed basis for remediation and any of your product safety needs
• Provide Product Safety Design Support, including Gap Analysis/Construction Evaluation, Review and generation of product Labeling and Markings, assistance in the selection and review of safety critical components
• Provide Gap Analysis on your product(s) to IEC 60601-1, 3rd Edition
• Provide IEC 60601-1, 3rd Edition Risk Management File support
• Provide IEC 60601-1-2, EMC support including Test Plan Preparation, Essential Performance Analysis, and full Marking and Labeling support
• Support Test Agency Submissions, including Interface with the Test Agencies (UL, CSA, TUV, NEMKO, Intertek, etc.)
CCA works with companies large and small, with as few as two employees. Most of our clients are smaller in size in need of high quality regulatory services, but found it impossible to afford a salaried regulatory professional.
Veteran Owned Company
Located in Prescott – Servicing Phoenix, Flagstaff, and So Cal areas.
Principals and associates resumes available on request
A sampling of our clients and services we provided to them are available on request.
For further information, or to schedule and appointment on any of our services, please contact us.