Ethics & Compliance Program

Ethics & Compliance Program

Ethics & Compliance Department Mission Statement

Foster a culture of ethics and trust, where management leads by example; where employees are inspired and empowered to do the right thing; where products are sold based on competence, and day-to-day compliance with applicable rules and standards is a part of everyone’s objectives.


“In today’s business environment, it’s vital that employees are empowered to make ethical decisions in their day-to-day work that align with the organization’s values and principles," said Ryan Walters, President of BIOTRONIK, Inc. "Here at BIOTRONIK, we are committed to our ethical principles, and embrace the importance of trust and integrity in the workplace every day. We depend on, and expect, this commitment to ethical behavior not only from our leadership teams, but from each and every one of our employees. If you have any questions, you are welcome to reach out to us. We look forward to hearing from you.”


Leading with Integrity: BIOTRONIK Code of Business Conduct

Our Code of Business Conduct is about maintaining our good reputation by defining our values and principles, and is used as a resource to help BIOTRONIK employees make the right decisions and resolve ethical issues. All BIOTRONIK employees and sales representatives are required to be familiar with and to abide by our Code of Business Conduct.


MESSAGE FROM THE VP of Regulatory & Compliance:

“We are committed to helping guide, train, inform, and coach our colleagues as it relates to the business expectations and regulatory and compliance requirements that BIOTRONIK operates under. We believe that our employees want to do the right thing, and we are here to provide the “road map” to help each of you make ethical decisions and navigate your day to day jobs with pride, confidence, and integrity.”

Jon Brumbaugh, VP of Regulatory and Compliance

Email: jon.brumbaugh@biotronik.com

Phone: 503-451-8310

BIOTRONIK is proud to support our employees with a strong team of legal and compliance professionals with expertise and experience leading medical device organizations focused on ethical business practices and strict adherence to all applicable laws and regulations. BIOTRONIK takes these responsibilities seriously and has implemented a comprehensive compliance program to meet these goals.

To contact the Legal team, please call (503) 451-8013
To contact Ethics & Compliance, please call (503) 451-8310


Reporting a Concern: Resources

BIOTRONIK provides a number of resources that employees and others can use to ask a question, obtain guidance, or report a concern.


COMPLIANCE HOTLINE:

Call the BIOTRONIK reporting hotline, a toll-free telephone number that anyone can call, 24 hours per day, seven days per week: 1-800-398-1496

Make a report online at https://www.lighthouse-services.com/ (Select “Submit a Report”, enter your LoginName and Password)

LoginName: Biotronik

Password: Blue

The Compliance hotline is not designed for reporting product complaints. If you are not a BIOTRONIK employee and need to report a product complaint, please call the Medical Device Reporting Department at 1-877-245-9800. BIOTRONIK employees, please follow corporate complaint reporting guidelines.


Your Responsibility

All BIOTRONIK personnel are expected to adhere to the BIOTRONIK Code of Business Conduct, as well as all applicable laws, regulations, and BIOTRONIK policies. If any BIOTRONIK personnel becomes aware of a violation or a possible violation of this code, or has any concerns at all, the individual should report it immediately to his or her supervisor, the Compliance department, or via the Compliance hotline. All reports will be kept confidential to the greatest extent possible.

Non-Retaliation Policy

BIOTRONIK does not tolerate any form of retaliation against an individual arising from a good-faith report of a potential violation of our Code of Business Conduct, a related policy, or of an integrity concern. Retaliation is also prohibited against anyone who participates in an investigation of such a report. For additional information about calling the Compliance hotline, see Code of Conduct, Page 44.