ENEM Consulting provides clinical and quality systems support, to help ensure engineering and clinical deliverables align with regulatory strategy.
Clinical Study Strategy, Planning and Operations
- Clinical study design (Pilot and Pivotal)
- Protocol development
- Standard Operating Procedure (SOP) development
- Regulatory review of Protocol, Statistical plan
Clinical site Audits
Auditing of clinical study sites towards preparation for FDA BIMO audits, including:
- Regulatory Documentation review
- Institutional Review Board (IRB) Review
- Informed Consent and Individual Subject Issues
- Adverse Event (SAE/AE) Reporting
- Product Accountability
- Protocol Deviations
- Source Documentation review against Case Report Forms (CRFs)
Contract Research Organization (CRO) Audits
Conducted on behalf of the sponsor, the audits help ensure that the CRO is in compliance with Good Clinical Practice (GCP) regulations and will include:
- Verifying adherence to program specific procedures outlined in the clinical research protocol(s) and contractual agreements.
- Verifying data supporting the clinical trials are generated, recorded and reported in compliance with the protocol and SOPs.
- Training review
- 21 CFR Part 11 assessments
Conducted on behalf of the sponsor, the audits help ensure that the test laboratory is in compliance with Good Laboratory Practice (GLP) regulations and will include:
- Verifying adherence to program specific procedures outlined in the animal research protocols, to ISO 10993 requirements and contractual agreements
- Verifying that data supporting the animal studies are generated, recorded and reported in compliance with the protocol and standard operating procedures.
Quality Systems Support
Quality Systems development to FDA QSr and ISO 13485 regulations including:
- Developing Standard Operating Procedure(SOPs)
- Developing and managing project plan for Quality Systems implementation
Preclinical test Planning
- Assistance with test plans to address IEC 60601, UL601, ISO 10993 and, other US and International standards
- Assistance with developing Software documentation to FDA guidance and IEC 62304 standard
- Training to FDA QSr, design control requirements
Assessing the manufacturing processes associated with components including:
- Printed Circuit Board (PCB) assemblies, optical and electrical cables, machined and injection molded parts, electromechanical assemblies including finished medical devices.
- Evaluation of business fit of supplier to OEM
- Supporting Lean Manufacturing Implementation