Consultants

KEN BLOCK
President and Founder

Background:
BS Physics + 20 years professional experience in regulatory affairs, quality systems, R&D, product and process improvements, medical device manufacturing, validations, testing, and lasers.

Certification:
Kenneth L. Block has earned the Regulatory Affairs Certification (U.S.) from the Regulatory Affairs Professionals Society (RAPS). The RAC (U.S.) is earned through professional examination regarding comprehensive knowledge of FDA and related U.S. regulations, policies, and guidelines in the areas of medical devices, drugs, and biologics. The RAC (U.S.) designation is a mark of distinction for regulatory professionals dealing with FDA products and issues including strategic planning, design and development, pre-market and regulatory review, manufacturing quality systems, marketing, post-approval, and FDA interfacing.

Darren Henderson
Director - Quality Systems and Business Development

Darren Henderson is managing the overall operational marketing, customer relationship, and quality system related activities. He is committed to providing the highest level of quality service to our clients.

With more than 25 years of regulatory, quality and medical device experience, Mr. Henderson has assisted clients with internal audits, gap analysis, field corrections, recalls, quality system development as well as Health Canada applications and recalls. 

Mr. Henderson holds a bachelor’s degree in management from Texas A&M University at Commerce, a lead auditor certification from American Society for Quality (ASQ), and a RAC from the Regulatory Affairs Professional Society (RAPS).

DIANE RUTHERFORD
Director - Regulatory Operations and Development

Diane Rutherford is responsible for oversight of all submissions related activities for Ken Block Consulting. Her efforts focus on the successful outcomes of submissions to FDA, such as premarket applications.

As a trained engineer, she entered the medical device industry in product development, finally transitioning to Regulatory Affairs. This experience has contributed to her successes in assisting clients to receive marketing clearance for their devices. In addition to submissions related activities, she also assists with: development of regulatory strategy; presentation of seminars in the U.S. and Japan; development and improvement of quality system documents; product testing and validations; research reports on various client requested topics.

Ms. Rutherford holds a Bachelor of Science in Mechanical Engineering from the University of Texas in Arlington and a Master of Science in Materials Science Engineering from the University of North Texas. Prior to joining Ken Block Consulting, Ms. Rutherford spent ten years in a senior product development position with a medical device manufacturer of single use, disposable, safety sharps devices. In addition to her experience in design control and quality system regulations, she has a background in sterilization and packaging.

To keep up to date on the rapidly changing medical device industry, Ms. Rutherford attends seminars and conferences and maintains membership in several professional organizations including Regulatory Affairs Professionals Society (RAPS), American Society for Quality (ASQ), American Society for Testing and Materials (ASTM), Institute of Electrical and Electronics Engineers (IEEE), Association for the Advancement of Medical Instrumentation (AAMI), Society of Plastics Engineers (SPE), and American Society of Mechanical Engineers (ASME).

ISOKO HIRASE
Regulatory Specialist

A native of Japan, fully fluent in English and Japanese, Isoko Hirase joined Ken Block Consulting in 2007. Since then, she has been involved in a variety of consulting projects, including FDA inspection support, quality system improvement, gap analyses, quality audits, and training and seminars. Ms. Hirase has also honed her interpretation and translation abilities over the course of her involvement in regulatory affairs, and has served as interpreter during audits, FDA inspections, negotiations, and more. Some of the tasks that she manages while working out of KBC’s Dallas headquarters include the creation of responses to FDA Warning Letters or Form 483 observations, and review of quality system procedures. Ms. Hirase has represented KBC at numerous international events. She was invited as a guest speaker to conferences at MEDTEC 2012, Fukushima Innovation Beyond, and Fukushima Medical Industry Integration Project 2014.

Ms. Hirase holds professional certification in regulatory affairs (RAC).

LACEY HARBOUR
Regulatory Specialist - Validation

As Ken Block Consulting’s Validation Specialist, Lacey Harbour utilizes her ten years of science academia and industry experience to develop robust risk-based software and process validation procedures. Ms. Harbour has assisted numerous clients with the goal of creating in-house validation specialists. Her efforts have included the training of client teams on how to approach validation, as well as all applicable supporting subjects. Ms. Harbour performs tailored seminars, workshops, and one-on-one training in areas such as current Good Documentation Practices, calibration, installation, software validation, CLIA, comparion devices, and others. Ms. Harbour holds a Bachelor of Science in Biology and a Master of Science in Biology (focus on molecular biology) from the University of Texas of the Permian Basin (UTPB). Her background in experimental design, calibration, and instrumentation is built upon years of academic research at UTPB and the University of Texas Southwestern (UTSW). Ms. Harbour has a keen interest in Japanese language and culture, studied Japanese while in Japan, and is able to read, write, and speak Japanese on a conversational level. Ms. Harbour also taught English to Japanese students during her tenure in Japan. Prior to joining KBC, Ms. Harbour continued her validation and regulatory experience, working in a high-complexity, high-throughput, CAP/CLIA-certified Laboratory Developed Test (LDT) laboratory.

To keep current with the most recent validation techniques and FDA validation matters, Ms. Harbour attends training seminars, reads relevant publications, and studies FDA releases.

AKIKO DOHI
Regulatory/Research Specialist

After more than 10 years in biomedical and neuroscientific research, Dr. Dohi joined KBC as a regulatory and research specialist. Dr. Dohi is currently involved in design history file (DHF) remediation and recall support. She also works with clients on scientific thinking and applies her biomedical research expertise in numerous ways while generating solutions.
 
Dr. Dohi is native Japanese and is bilingual in Japanese and English. She holds a Bachelor of Science in Biology, with a minor in Chemistry, from the University of North Texas and earned her Ph.D. in Biomedical Sciences, with an emphasis in Pharmacology and Neuroscience, from the University of North Texas Health Science Center. The topics she focused her studies on include steroidal hormone regulation of the GABAergic system, the neuroprotective effect of steroidal hormones, and the neuromodulatory effect of obesity on baroreflex. 

Katie Reneson
Regulatory Specialist

As a regulatory specialist at Ken Block Consulting, Katie Reneson has assisted multiple clients with successful 510(k) submissions for a wide range of device types. With more than eight years of industry experience, she uses her extensive knowledge in device validation, software validation, process validation, 510(k) applications, and European Medical Device Regulation/In Vitro Diagnostic Regulation to solve complex regulatory compliance problems. 

Ms. Reneson holds a Bachelor of Arts in Biology with a minor in Psychology from Augsburg College. She is currently working toward a Master of Science in Quality Assurance, Manufacturing option, at California State University. She keeps current with regulations and industry trends by attending training, seminars, and conferences, occasionally as an invited guest speaker at events such as MedTec Europe 2018 and Medical Technology Ireland 2018.