Engineering and Regulatory Support
Medical Device Compliance
Medical Device Compliance
At cGMP Consulting, we understand the importance of maintaining regulatory compliance for medical device manufacturers. With over 20 years of experience, we’ve honed our expertise in delivering high-quality, safe, and compliant solutions tailored to each client’s unique needs while meeting the highest standards.
Our consulting services encompass a wide range of subjects relevant to medical device manufacturing such as:
- Quality Assurance and Control
- Equipment Qualification
- Process Validation
- Documentation and Record-keeping
- Risk Management
- Supplier Qualification
We take pride in not just meeting regulatory standards but also driving business excellence. Our engineering team will work closely with your team to develop the desired scope, deliverables, and timeline to suit your needs. We provide valuable insights and guidance, ensuring that your medical device manufacturing operations are not only compliant but also efficient, reliable, and competitive.
Together we will mitigate compliance risks, optimize operations, and achieve sustainable success in an ever-evolving, highly regulated industry.
Which category of medical devices could we assist you with?
- Single use devices
- Implantable devices
- Imaging devices
- Medical equipment
- Software
- In vitro diagnostics
- Personal protective equipment
- Surgical and laboratory instruments
- Non-invasive devices, invasive devices, and active devices
