Services
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For start-up and small companies, we provide expertise and services on a part-time basis without the commitment and cost of full-time personnel.
For larger companies and companies in transitions, we provide expertise and experience for functions that may be overloaded or not fully developed in your company.
Areas of expertise
Quality System Implementation and Transition Strategy: Cost-effective, timely strategies for quality system implementation. Quality systems can be developed from scratch for an independent start-up. Existing quality systems can be modified to meet new requirements, such as ISO 13485 or ISO 9001:2000. Multiple quality systems can be aligned in acquisitions and corporate reorganizations.
Quality System Audits, Gap Analysis, and Action Plans: Review and evaluation of quality systems to assess compliance, identify opportunities for improvement, and propose methods to overcome deficiencies.
Due Diligence Reviews: Evaluation of regulatory status and compliance of products and quality systems.
Quality Management: Support of management teams to integrate quality management into business practices.
Quality System Implementation Assistance: Tailored services to develop and oversee implementation of quality system elements.
Compliance and Emergency Assistance: Rapid assistance for urgent situations with high regulatory exposure, such as Form 483 observations, Warning Letters, Notified Body audit observations, or recalls.
Product Approval Submittals: Coordination with product design teams to prepare and submit 510(k)'s and Technical Files. |
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