Cooperative Quality Solutions
Cooperative Quality Solutions is dedicated to helping clients achieve integrated medical device compliance that supports their business success. They specialize in designing, improving, and maintaining user-friendly quality management systems (QMS) for medical devices, with expertise in US FDA and EU regulations, including EU MDR and CE marking. Their services include QMS implementation and improvement, gap assessments, fractional services, nonconformance remediation, education, and product development. The company focuses on small companies and has over 15 years of experience working with US and EU markets.
Industries
Nr. of Employees
small (1-50)
Cooperative Quality Solutions
Products
QMS procedures and template package
A set of procedures and templates for medical device QMS implementation and maintenance that are positioned as compliant to US and EU regulations and to international standards.
Greenlight Guru eQMS
An electronic quality management system (eQMS) designed exclusively for the medical device industry that is minimally configurable and pre-validated.
Grand Avenue Software eQMS
A modular electronic quality management system (eQMS) designed exclusively for the medical device industry, offering specific eQMS modules and pre-validation.
QMS Procedures and Forms
A set of medical device QMS procedures and forms incorporating requirements from FDA QMSR, ISO 13485, EU MDR, ISO 14971, EN 62366-1, and ISO 62304. Available as individual process bundles or as a full system.
Qualio eQMS
An electronic quality management system for life science companies featuring high configurability to meet specific organizational needs.
Paper QMS
A traditional paper-based quality management system that requires no eQMS software.
QMS procedures and template package
A set of procedures and templates for medical device QMS implementation and maintenance that are positioned as compliant to US and EU regulations and to international standards.
Greenlight Guru eQMS
An electronic quality management system (eQMS) designed exclusively for the medical device industry that is minimally configurable and pre-validated.
Grand Avenue Software eQMS
A modular electronic quality management system (eQMS) designed exclusively for the medical device industry, offering specific eQMS modules and pre-validation.
QMS Procedures and Forms
A set of medical device QMS procedures and forms incorporating requirements from FDA QMSR, ISO 13485, EU MDR, ISO 14971, EN 62366-1, and ISO 62304. Available as individual process bundles or as a full system.
Qualio eQMS
An electronic quality management system for life science companies featuring high configurability to meet specific organizational needs.
Paper QMS
A traditional paper-based quality management system that requires no eQMS software.
Services
Develop, implement, and improve medical device quality management systems and related processes.
Assess QMS and product documentation against regulatory and standards requirements and provide remediation plans.
Provision of interim or part-time QA resources to handle routine quality assurance responsibilities.
Remediate nonconformances and align systems and documentation with regulatory body expectations.
Create customized training courses and company curricula focused on QMS and regulatory topics.
Assist in defining product requirements to enable straightforward verification and validation.
Develop, implement, and improve medical device quality management systems and related processes.
Assess QMS and product documentation against regulatory and standards requirements and provide remediation plans.
Provision of interim or part-time QA resources to handle routine quality assurance responsibilities.
Remediate nonconformances and align systems and documentation with regulatory body expectations.
Create customized training courses and company curricula focused on QMS and regulatory topics.
Assist in defining product requirements to enable straightforward verification and validation.
Expertise Areas
- Quality management systems for medical devices
- Regulatory compliance (US FDA, EU MDR)
- QMS implementation and gap assessment
- Fractional quality assurance services
Key Technologies
- Electronic quality management systems (eQMS)
- Paper-based quality management systems
- ISO 13485
- ISO 14971 (risk management)