Reliable Engineering Services supports a wide range of medical device companies on product development and manufacturing projects in the US and overseas. Our team of technical professionals includes engineers, microbiologists, designers, technicians, information technologists and regulatory specialists. As the founder and principal engineer, I connect people and projects using established relationships from years in the industry. Our technical team is continually learning the shifting regulations and standards, and we collaborate with organizations to introduce new regulations into quality systems. At Reliable, we are exposed to many different, client-based methodologies for product development and quality, and we adapt accordingly. The Reliable organization is highly flexible, serving the broadest range of clients, including individual surgeons with novel inventions for patient care to multinational conglomerates, from Class 1 devices to Class 3 life-supporting implants. Some of our skills: Product Development, Risk Analyses, Validation and Verification (V&V), Design of Experiments (DOE), Quality Systems, Process Validation, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Equipment Qualification (EQ), Software Validation, Design Inputs, Failure Modes and Effects Analysis (FMEA), Design Outputs, Device Specifications, Design Verification (DV), Design Validation, Design History Files (DHF), Sterilization, Good Manufacturing Practices (GMP), ISO 13485, IEC 60601.