We help build and maintain a successful business. How? By ensuring that:
- Effective controls are in place, and that they are capable of meeting process and product requirements,
- That the business is compliant with applicable U.S., industry and international medical device standards and regulations, and
- That customer requirements are being met.
We are committed to, first, understanding the organization’s problems. Then:
- We work with them to get an idea of why these problems exist, then
- Assist identifying and recommending the best sustainable solutions.
We ensure that business and quality management systems are effective and support the organization’s objectives.
How Innovative Quality Consulting Began
With 35 years of experience in the medical device industry, and a passion to help build and grow successful businesses, it was time to make a change. Since 2015, Ron Makar, the owner and founder of Innovative Quality Consulting, LLC, has worked with several medical device companies in various capacities. In addition to his consulting work, he is an independent contractor for DEKRA Business Assurance (www.dekra.com), auditing clients for compliance to ISO 13485:2016 and ISO 9001:2015.
Consulting projects successfully completed:
- Performed a quality management organizational capability assessment for a start-up combination products organization.
- Provided U.S. FDA Quality System Regulation compliance guidance to an international medical device company.
- Performed quality process and system assessment, process mapping and system improvement guidance and recommendations to promote a more effective service & repair operation for an international medical device company.
- As a member of a multi-member FDA compliance remediation project team, led efforts to bring into compliance supplier quality and purchasing process controls for an international medical device company headquartered in Japan.
- As a consultant team leader, was responsible to harmonize into a single management system, thirteen (13) globally diverse medical device and pharmaceutical product development processes.
From quality systems auditing, to product development process redesign, to FDA remediation and corrective action activity, Ron has been able to help his clients develop better systems to meet their business objectives and quality and regulatory requirements.
Meet the Founder, Ron Makar
Ron is a dedicated, well-organized, quality professional with vast experience in:
- product, process and quality engineering
- auditing and audit program management
- product development and commercialization
- field service systems & technical support
- regulatory compliance
- manufacturing, supplier and quality management
His professional background includes industry experience in in vitro diagnostic (IVD) medical devices, digital imaging systems, interventional devices, bio-based materials, and bio-polymer devices and delivery systems.
Key roles in which Ron has supported include:
- product development, process, systems support and quality management engineer
- quality assurance and production supervisor
- manufacturing plant quality assurance and global quality manager
- director of quality management systems
Ron has made significant contributions during his employment at E.I. DuPont de Nemours & Co., Dade Behring, Inc. (purchased by Siemens Medical Solutions in 2007), W. L. Gore and Associates, Hologic Inc., and Actamax Surgical Materials, LLC. His accomplishments include:
- overseeing the implementation of a Total Product Quality Management System for the DuPont Diagnostics manufacturing organization
- establishing and certifying several quality management systems to ISO 9001, ISO 13485 and ISO 14971
- the qualification of several supplier contract manufacturing organizations
- serving as quality assurance and management representative for several product development and management systems
- identification and implementation of procedures to reduce manufacturing variability to acceptable levels
- leading efforts to implement an electronic customer complaint handling and corrective and preventive action (CAPA) system (www.etq.com) in the DuPont Industrial Biosciences business unit, which led to a corporate project to implement this system throughout the company
- Auditing (Process, Product, System, FDA QSIT)
- Change Initiatives / Change Controls
- Change Management
- Combination Products
- Council Directive 93/42/EEC
- Critical-to-Customer / Critical-to-Quality Requirements
- Design & Development Planning
- Design Controls
- ISO 9001 / 13485 / 14971
- Manufacturing SOPs / Work Instructions
- Process Development / Process Controls
- Process Improvement & Process Mapping
- Project Management
- Process Validation (IQ/OQ/PQ) – Software, Hardware, Systems
- Quality Engineering, QC & QA
- Quality Management, QMS Certification
- Risk-based Thinking, Risk Management
- Supplier Qualification & Supplier QA
- QMS & Audit Training
- U.S. FDA QSR Remediation
- U.S. Title 21 CFR Parts 11/803/806/807/810/812/814/82
(American Society for Quality)
- As a Senior Member of the American Society for Quality (ASQ) since 1989, Ron maintains the following certifications:
- CBA: Biomedical Auditor (Certification No. 772)
- CHA: HACCP (Food Safety) Auditor (Certification No. 787)
- CMQ/OE: Manager of Quality/Organizational Excellence (Certfication No. 3187)
- CQA: Quality Auditor (Certification No. 10, 459)
- CQE: Quality Engineer (Certification No. 35,016)
- CSQP: Supplier Quality Professional (Certification No. 574)
Selected Presentations Made by Ron
Managing Product Risk from Cradle to Grave
Presented at American Society for Quality (ASQ) World Conference on Quality and Improvement, Dallas, TX, (5/14)
How Healthy is Your Ability to Manage Risk? (Thoughts on Risk Based Thinking Requirements in ISO 9001:2015)
Presented at March 2016 ASQ Delaware Section Dinner Meeting, Wilmington, DE
ISO 13485:2016 – Preparing for the International Medical Device Standard
Presented at the 16th Annual Product Complaints Congress for Life Sciences, June 20, 2018, Arlington, VA