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ABOUT US

In February 2022 Yasha Patwardhan founded PatwardhanMed Consulting with the goal to provide high quality regulatory compliance and quality management system consulting services for medical device and pharmaceutical clients. The focus at PatwardhanMed Consulting is to listen, learn and analyse before providing any solutions. Throughout her 14+ years of experience, Yasha understands that there is no one-size-fits-all approach to reducing complexity and redundancy in both Risk Management and QMS processes, as well as strategies for maintaining regulatory compliance. In fact her decision making leads to client satisfaction.

Client satisfaction is of the utmost importance in this industry, yet the largest single value a consultant brings is their network of trusted teammates and affiliates. Throughout network, we strive to avoid situations where clients are stuck “cleaning up” after consultants, because the changes implemented do not work for them in the long run -- it undermines professional credibility. philosophy is simple, 'if you would not cook it in your kitchen, don't recommend it to someone else'.  

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We understand that medical device regulations leave a fair amount to interpretation and that quality management systems are complex .

Over the last 15 years, we have worked across the major functions of several multi-national medical device companies.
We have a balanced view of what works and hinders strategic and remediation project success and outcome longevity.

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Curiosity

OUR NETWORK

Yashaswini Patwardhan

Yashaswini Patwardhan

CEO & Founder, US & DE

Yashaswini Patwardhan started her journey in the medical device industry 17 years ago as an intern in Los Angeles and graduated with an MS in Biomedical Engineering from the University of Southern California shortly after. The intern position led to a job opportunity in Buffalo, New York in 2006, where she worked with both small and large medical device manufacturers within Western New York. During these 8 years, she gained a solid footing in 21 CFR Part 820 quality management systems (QMS) requirements and 510 (k) market authorization pathway.

When an opportunity arose to join a consulting project in 2014, she engaged fully. This decision was truly life changing, since it meant working on a project in Germany alongside other consultants. The 3.5 years there grew her professional network internationally and further enhanced her knowledge and experience in FDA QMS remediation and eventually led to her first project tackling CE marking. With the introduction of MDR around that time and its coming into force in May 2021, it has been a whirlwind of activity assisting clients with MDD-MDR transition both in Europe and the USA, while also being engaged in FDA enforcement action related QMS remediation.

Amid all this, in August 2021 Yasha acquired an Executive MBA from the Quantic School of Business and Technology.

Thomas Dzierozynski

Thomas Dzierozynski

Managing Director, TJKA, US

C-Suite Level Medical Device Professional, 25+ years experience

Ferdinand Bahlmann, M.D., Ph.d

Ferdinand Bahlmann, M.D., Ph.d

Managing Director, Bahlmann Life Sciences, DE

Highly experienced medical device professional from SME to Fortune 100, 15+ years experience

WORK

What we've done for clients

EU MDR: We currently manage all activities of the EU MDR transition--reviews, submissions, labeling, and correspondence with Notified Bodies.
US FDA: For pre-market situations, we prepare 510(k) submissions and drive regulatory strategy to support commercialization.
US FDA and EU: Post commercialization, we setup and improve processes to handle regulatory reviews of changes to device design, labeling and manufacturing processes.
21 CFR Part 803 MDR: we create and improve medical device reporting processes for all sizes of clients internationally. When scaling inevitably occurs, we design workflows and implement necessary trainings that maximize operational efficiency.
WARNING LETTERS AND 483 RESPONSES: We have experienced the best and worst case scenarios, so we can prepare and coordinate responses with the FDA to AVOID further enforcement.
DEVICE LIFECYCLE MANAGEMENT: We apply risk based methodologies to post market data analysis, trend reporting, complaint handling and escalation processes to ensure that potential device design or manufacturing process flaws are detected early and approrpiate measures are taken to remedy them.
RISK MANAGEMENT: We review current state to propose feasible solutions to different risk types and shape policies and procedures accordingly. As regulations and standards update, reviews and resulting proposals can be adapted to the firm's needs to address gaps and remediation concerns.

Skills.

Medical Device Regulations

Medical Device Quality Management Systems

Continuous Improvement

Validation

Root Cause Analysis

CONTACT

Lets get in touch. Send us a message:

Karlsruhe, DE

Phone: +49 1 60 813-7497

Email: info @ patwardhanmed.consulting