About us

 

A. A. Rankis & Associates, Inc.

A. Arthur (Art) Rankis, Founder and President of A. A. Rankis & Associates, Inc., has over 25 years of US and International Medical Device and Biotech experience in Regulatory Affairs and Quality. Art has been consistently at the forefront of implementing new regulatory and quality requirements: the original US GMPs, MDR, ISO 9001, QSR, MDD-CE, ISO 13485, CMDCAS and others. He has extensive experience in: FDA, CE, and CMDCAS auditing and audit management; product approvals (510k, PMA, Technical Files, Design Dossiers, etc.) and various other regulatory submissions; risk management; design control; interacting with regulatory agencies; quality system implementation, repair, and improvement; executive management responsibilities; training; product and process validation planning and implementation; supplier management; sampling and inspection; and regulatory strategies. Art has successfully guided many companies through FDA, CE, CMDCAS (and other international) inspections, issues, and regulatory approvals.

Art uniquely brings practical and workable solutions to Regulatory and Quality challenges for a broad range of Devices, Biologics and Diagnostics: All classes of devices-PMA-510k-Class I, implants, bio-absorbables, software and hardware, serviceable, blood contact and intra-venous, sterile, non-pyrogenic, disposable, drug-delivery, optical, electrical, mechanical, reusable, machined, molded, extruded, purification, filtration, film-cast, and non-wovens. He works with companies that range from 2 person startups to multinationals. He also provides training to companies in areas such as Managing FDA and CE inspections, Quality and Regulatory Fundamentals for Medical Device Companies, Inspection and Statistical Sampling with ANSI/ASQ Z1.4, and other subjects.

Prior to establishing his consulting practice, Art held the leadership position in Regulatory and Quality for Bausch & Lomb Inc., Millipore Corp., Smith & Nephew Inc., HemaSure Inc., Cytyc Corp., and Insulet Inc.

Art is a founding board member of the ASQ Biomedical Division’s New England Discussion Group, is on the Independent Certification Board of NQA-USA, a US based Quality System Registrar, was on the Board of Examiners for the Malcolm Baldrige National Quality Award, was a member of the AAMI-Blood Filtration Technical Committee, and is a long time active member of RAPS, AAMI, and ASQ. Art has a B.Sc. degree in General Science and Education from the Vermont State College at Lyndonville VT, an Associates degree in Quality from the Ryerson Polytechnic Institute in Toronto, Ontario, and he is an ASQ certified Quality Engineer. 

Art is often invited to speak on various current topics and areas of his expertise. 

 

Presentations and Publications 


Guidelines for Successfully Managing FDA Inspections
ASQ Tri-Division Conference, Arlington VA.  

Achieving the CE Mark and ISO-9000 Certification
ASQ’s Northeast Quality Conference, Falmouth, MA.

Supplier Quality Management: What’s new, What’s working, What’s not
ASQ World Conference on Quality and Improvement, Orlando, FL.  

Management Responsibility and FDA Inspections
ASQ's Biomedical Division, Needham, MA.

Collaborating With the Customer for Product Design and Customer Satisfaction
The Conference Board’s Annual Marketing Conference, NY, NY.

Successful Inspections: ISO 13485 and FDA
ASQ Worcester Section Meeting, Worcester, MA.

Technical Documentation for MDD - European CE Mark Compliance for All Classes of Devices  ASQ’s Biomedical Division, Needham, MA. 

Developing a Robust CAPA System
ASQ's Biomedical Division, Waltham, MA.

A Strategy for the Manufacture and Control of High Quality Pharmaceutical Filters
Parenteral Drug Association’s Annual Conference, Philadelphia, PA. 

Subcontracting Quality Responsibilities
ASQ’s Annual BOSCON Conference, Burlington, MA. 

The Lifecycle of a Medical Device
ASQ’s Biomedical Division, Needham, MA.

The CQT Manual, A Handbook for Quality Technicians and a Refresher for the ASQC Certified Quality Technician Exam