qualityworks. services

navigating the complex and ever-changing regulatory landscape is crucial for the timely and successful launch of medical devices across global markets. Each market presents its unique challenges, from varying regulatory requirements to diverse registration processes, making strategic regulatory planning essential. At qualityworks., we specialize in aligning regulatory activities with your business strategy, ensuring your product reaches its target markets efficiently.

Our approach not only offers a clear direction for your project team but also proactively identifies and addresses potential challenges, streamlining the path to market. We understand that for small and medium-sized companies, strategic planning may seem daunting. Yet, the long-term benefits of such planning, including cost and time savings, cannot be overstated.

Let qualityworks. guide you through the regulatory maze, helping you mitigate risks and avoid costly delays, ensuring a smoother journey for your product from concept to market. Save time, money, and effort by leveraging our expertise in regulatory strategy and compliance management.

qualityworks. QMS services: 

• Establish a staged quality system implementation during product development all the way to ensuring compliance readiness at the time of registration and listing
• Establish, maintain or upgrade quality systems to ensure compliance with ISO 13485, FDA Quality System Regulations, EU MDR, MDSAP, and other global requirements (as applicable) 

qualityworks. has the knowledge and experience to write it right, train your staff and implement an effective quality system that works for you.

qualityworks. regulatory affairs services:​

• Regulatory submissions
• Device Registration and Listing
• CE Marking Compliance
• Technical Files preparation and  maintenance
• Complaint management
• Adverse Event Reporting
• Regulatory support after product launch

We have the knowledge to help you navigate the regulatory landscape.

certified auditor with extensive industry experience will provide you an unbiased, thorough evaluation per your need:

• Gap Assessments
• Internal Audits
• Supplier Audits
• Mock FDA Inspections
• Product/Process Audits
• Due Diligence

Let qualityworks. help you when and where it matters.

maintaining the quality management system after product launch requires tireless follow-up and tracking of regulatory compliance, followed by updates of documentation, verification and validation, and notifications of significant changes to regulatory authorities. 

qualityworks. can help you maintain and improve an efficient and effective quality management system that is continuously compliant with the applicable regulatory requirements.

Our QA/RA consulting services include, but not limited to:

• Internal and/or supplier quality audits
• CAPA system oversight and management
• Monitoring quality metrics and key performance indicators for Management Review
• Quality system training (1-on-1, group training, awareness trainings, etc.)
• Complaint handling and Adverse Event Reporting
• Mentoring and coaching junior QA or RA staff
• Improving QMS

We have the expertise to help you maintain an efficient and effective quality management system that is continuously compliant with relevant market requirements.

in today's dynamic environment, leveraging temporary consultants and contractors is crucial for maintaining productivity with leaner in-house teams. Our services ensure you navigate workforce fluctuations effectively, offering:

• Expert staff augmentation for temporary or long-term support.
• Industry-specific expertise that understand your unique needs.
• Flexible engagement across a variety of QA/RA roles, including but not limited to:
  • QA/RA Director
  • Quality Assurance Manager
  • CAPA Specialist
  • QMS Specialist
• Benefits of temporary consultants:
  • Accelerate project execution with immediate onboarding.
  • Bridge skill gaps and handle intense workloads seamlessly.
  • Gain insights into QA and RA role requirements and ideal candidate profiles.

 Embrace the flexibility and expertise of temporary consultants to meet the evolving challenges in the life sciences sector. Contact us to learn how this service can keep your projects on track and within budget.