COMPANY NAME: Noblitt & Rueland
ADDRESS: 5405 Alton Parkway 5A, #530
CITY, STATE, ZIP: Irvine, CA 92604
TELEPHONE: 714-258-4646
FAX: 714-258-3990
WEBSITE: www.fdaconsulting.com
E-MAIL: info@fdaconsulting.com
VITAL STATISTICS
YEAR FOUNDED: 1989
NUMBER OF EMPLOYEES: 15
NUMBER OF FACILITIES: Headquarters in Southern California
WHO WE ARE
Noblitt & Rueland offers specialized consulting expertise in FDA and ISO related issues such as GMP-QSR-QSIT, ISO 13485:2003, audits, software, electronic recordkeeping (Part 11), submissions (510(k), IDE, PMA, CE mark), design control, risk assessments, hazard analysis, software quality assurance, software compliance audits, independent verification and validation, testing, software development, 483 and warning letter assistance, and extensive in-house training.
MAJOR MARKETS
Primary Market: Medical Device Manufacturers and their vendors. Secondary Market: Pharmaceutical manufacturers needing assistance with Electronic Recordkeeping (21 CFR Part 11) and software issues.
SERVICES OFFERED
Noblitt & Rueland provides professional regulatory consulting & training services to the medical industry and its vendors.
Consulting services range from regulatory consulting on submissions (510(k), PMA, IDE, CE Marking) to quality compliance issues related to FDA’s quality system regulation (QSR) or good manufacturing practice (GMP). We can assess or audit your quality system as part of your internal auditing program or we can help you implement or transition to a new quality system such as ISO 13485:2003. In addition, we offer consulting services on international regulatory issues such as those required by Europe, Canada, Australia, etc. and includes expertise on the Medical Device Directives, ISO Standards, ISO 13485, ISO 14971, IEC 60601 compliance, and CE Marking.
Specialized Technical Regulatory consulting includes assistance with Design Control, Risk Management, Hazard Analysis, Software Quality Assurance, and software verification & validation. These services can be performed to assist with a submission or as part of the quality system implementation or assessment.
Electronic Recordkeeping and 21 CFR Part 11 has received much attention. Noblitt & Rueland can assist your company with assessing your electronic recordkeeping systems and determining what activities need to be performed in order to meet or comply with the scope and application of the regulation.
Noblitt & Rueland is a leader in professional training offerings and currently offers over ten (10) courses dealing with regulatory issues of the medical industry. Some of these topics include, Design Control, Risk Management/Hazard Analysis including ISO 14971, ISO 13485:2003, Auditing Techniques, Software Verification & Validation, FDA QSR/GMP & Inspections, IEC 60601-1, Electronic Recordkeeping & Part 11, 510(k) Submissions, CE Marking, etc. These course offerings are available for on-site training allowing numerous employees to attend and permit confidential topics to be discussed. Optional Workshops can be designed to have the participants employ the concepts learned on projects currently being worked on within the company.