Clinical/Quality Systems

Clinical Study Strategy, Planning and Operations

ENEM Consulting provides clinical, and quality systems support to help ensure engineering and clinical deliverables align with regulatory strategy.

Our Services include:

Clinical study design (Pilot and Pivotal)
Protocol development
Standard operating procedure (SOP) development
Regulatory review of the protocol, statistical plan

Clinical Site Audits

Auditing of clinical study sites toward preparation for FDA BIMO audits, includes:

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

GLP Audits

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 plans for Quality Systems implementation

Pre-clinical 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

Training to FDA QSR, design control requirements

Supplier Audits

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 the supplier to OEM
Supporting Lean Manufacturing Implementation