- Global regulatory expertise to help fast-track certification support for PPE approval
- Regulatory requirements for market access and in meeting NICE requirements for air breathing systems including ventilators for the UK, American and Asian markets
- Building technical files and submission of 510k for complete air breathing systems incorporating both hardware and software in fulfilling product specification requirements
- Are you trying to get a new product to a global market through a CE MDR Gap Analysis?
- Do you need support with Validation Management through Product Life Cycle?
- Does your Risk Management File need reviewing?
- Do you need help with your Quality Management System and continued development?
- Do you have CAPAs outstanding registered with your Notified Body?
- Do you need help with FDA Remediation, including Technical File (Medical Device File) Reviews?
- Do you need support with CMO Quality Agreements and Audits?
- Are your Internal Audits effective?
- Do you have training and development needs through MDD to MDR?
- Do you need help and support with your Non-Conformities to prevent reoccurrences?
The clock is ticking. We can help you with Gap Analysis and transition planning for Technical Documentation and Quality Management Systems. The compilation of Technical Documentation to meet the new requirements, including remediation, corrections and resubmission.
CE Marking Compliance
Managing and supporting all aspects of CE Marking, including Product Classifications, identifying Harmonised Standards, Risk Management, Usability, Labelling and compilation of Technical Files (Medical Device Files) including Design Dossiers, remediation of Notified Body findings for correction.
Global Market Registrations
Review and identification of regulatory requirements for global markets along with preparation of submissions, including 510k.
Design, implementation, management and auditing of Quality Management Systems to meet regulatory requirements including ISO 13485: 2016, FDA 21 CFR Part 820 and MDSAP recommendation.
Reviewing of Clinical Evaluation Reports to support regulatory requirements and MEDDEV 2.7/1 Rev 4. Providing support for Post Market Surveillance and Vigilance reporting.
Training and Development
Provide training from basic awareness of quality and regulatory requirements to specific topics, to help you and your team get to grips with compliance in real time.
Develop Master Validation Plan and procedures through site transfers and Product Life Cycle. Maintaining validation state through KPIs and scheduled product reviews.