QUALITY

We work closely with our clients. We can improve and customize your processes and associated documentation to reflect best practices in light of your unique needs.

Stillwater MedTech Consulting specializes in developing and implementing quality management systems (QMS).

Over the last 25 years, the principals of Stillwater MedTech Consulting have designed and implemented quality management systems (QMS) and provided quality assurance consulting services for medical device, drug, and combination product companies around the world. During that time, we have developed best-practice QMS processes and associated documentation to comply with the FDA QSR, ISO 13485, and related regulatory standards.

We partner with our clients and customize and adapt these best-practice processes and documentation to support their unique business needs. We believe the goal for every QMS should be to achieve minimum regulatory compliance and maximum business value. Regulatory requirements must be met for important reasons; however, it does no good to implement a system that only focuses on compliance and fails to create business value. That is why it is important to have an expert to assist in the development or improvement of your QMS.

Using a combination of strategic business capabilities, tactical process design and implementation skills, and our deep quality assurance expertise, Stillwater MedTech Consulting is uniquely qualified to help your company not only improve its QMS, but also overcome regulatory challenges that it may face.  Our experienced professionals have successfully assisted numerous clients resolve regulatory agency actions ranging from minor nonconformances to consent decrees.

Our specific areas of expertise include the following:

  • Gap Analysis

  • Documentation Review

  • Workplan Development

  • Project Management

  • Process Mapping

  • Business Process Redesign and Implementation

    • Design Control / New Product Development
    • Risk Management
    • Verification/Validation
    • Document Management
    • Supplier Evaluation
    • Supplier Management/Outsourcing
    • Process Validation
    • Complaint Handling
    • Corrective and Preventive Action
    • Training

  • Process Metrics/KPIs

  • Documentation Development

  • Employee Training Systems

  • Internal Auditing

  • Auditor Development

  • QMS Implementation

  • FDA QSR

  • ISO 9000

  • ISO 13485

  • ISO 14971

  • EU, South America, Japan, China regulations

Stillwater MedTech Consulting also offers its clients the opportunity to outsource the management and coordination of various QMS processes. This service provides growing companies with access to experienced and expert resources for less than it would cost to hire an equivalent resource as a full-time employee. This option is also useful to large companies experiencing a temporary disruption caused by the departure of a quality manager or executive.