Compliance & Legal

Baylis Medical Company Inc. (“We”, “us”, “our”, “Baylis”, “Baylis Medical”, or “the Company”) is committed to providing our customers and their patients with products and services that meet or exceed their needs and expectations of quality, reliability, safety and performance while meeting regulatory and legal requirements.


This page affirms Baylis Medical’s commitment to meeting all its obligations under applicable laws, regulations, relevant codes of practice and other corporate compliance standards.
 

Code of Ethics

At Baylis Medical, Corporate Social Responsibility has been one of our Core Values since the day our company was founded. It encompasses our obligations to our customers to provide the highest quality of service, our mandates to maintain our reputation of honesty, and our commitments to ensure ethical conduct in every business relationship.

Our Code of Conduct provides a framework for our employees to live by and uphold these values. All Baylis employees around the world are expected to be familiar with and abide by our Code of Ethics
 

Compliance Program

The fundamental elements of our compliance program are described below. Note that our compliance program is constantly evolving to meet the changing needs and demands of the compliance environment and of Baylis Medical.

Policies and Training
Our Code of Ethics and Compliance Manual are essential features of our compliance program, providing guidance on business conduct and practices to all Baylis employees and contractors. Baylis continues to develop internal policies to guide ethical business conduct as compliance needs continue to change in the face of new legislation, regulatory practices, and association standards. We routinely train employees about these initiatives and also ensure that our suppliers and distributors are educated on the ethical and legal standards that we hold ourselves to.  

AdvaMed and MedTech Codes of Ethics
Baylis subscribes to the AdvaMed Code of Ethics, the Medtech Canada Code of Conduct, and the Medtech Europe Code of Ethical Business Practice in its professional dealings. These organizations are dedicated to advancing healthcare by encouraging innovative technologies and devices, ensuring integrity and patient-centric approaches in their sale and distribution. 

Because the relationships between AdvaMed’s and Medtech’s Members and Healthcare Professionals are so important, we ensure that all our employees, suppliers, and distributors are trained to follow relevant compliance guidelines in every business interaction. 

Laws and Regulations
Baylis is committed to promoting highest standards of ethical business conduct and compliance with all applicable laws, rules, and regulations.  It is our policy to comply with any and all applicable provisions of the U.S. Foreign Corrupt Practices Act of 1977, as amended (FCPA), the U.K. Bribery Act of 2010 (Bribery Act), other anti-bribery laws, and local laws. This applies to our employees, suppliers, and distributors around the world.

All of our employees and representatives are prohibited from, either directly or indirectly: (1) offering, requesting or receiving a bribe from any individual or entity, whether public or private; and (2) giving, offering, or authorizing the offer or giving of anything of value (such as money, gifts, goods, or a service) in order to receive an improper advantage from:
•    any government official or employee (including state-owned enterprises);
•    any person or firm employed by or acting for or on behalf of any government;
•    any political party (or party official) or candidate for political office (or party position); 
•    any officer or employee of public international organizations (e.g., United Nations); or
•    any family member or other representative of any of the above.
 

Statement on HIPAA Compliance

We understand that most of our U.S. customers are “Covered Entities” under the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations. As HIPAA Covered Entities, our customers are legally obligated to maintain the privacy of all patient information that they create or receive.

Since Baylis Medical does not obtain patient data in any capacity, we are not a HIPAA Covered Entity. Nevertheless, we recognize the impact that HIPAA privacy and security regulations have on our customers. Baylis remains committed to interacting with our customers and their patients as responsible professionals who are dedicated to maintaining the privacy of information that we receive on the job, consistent with applicable law and regulations.

We ensure that our customers comply with HIPAA provisions in their interactions with patients. When we receive information about patients related to the effectiveness of our devices, such information has been anonymized by those responsible for processing such information.   
 

California Compliance Statement

California requires medical device manufacturers to post information relating to their compliance program and provide an annual declaration as to compliance with its elements. To view our California Comprehensive Compliance Program and related declaration, click here.
 

Contacting the Legal Department

Baylis Medical Company is committed to the highest standards of openness, honesty, integrity, and accountability. In line with that commitment, we expect anyone who has serious concerns about any aspect of Baylis’ work to come forward. 

Anyone who files a report can do so with anonymity, and without fear of victimization, retaliation, subsequent discrimination or disadvantage. If any wrongdoing is identified and reported to us, it will be expedited, thoroughly investigated, and remedied. We will further examine the means of ensuring that such wrongdoing can be prevented in future. 

Wrongdoing involves any unlawful or illegal behavior and can include: 
•    Breach of or failure to implement or comply with any approved policy; 
•    Violations of our Code of Ethics
•    Violations of standards as set out by the Advanced Medical Technology Association (“AdvaMed”) or the Medical Technology Association of Canada or Europe (“MedTech Canada” or “MedTech Europe”)
•    Knowingly breaching municipal, federal or provincial laws or regulations; 
•    Unprofessional conduct or below recognized, established standards of practice; 
•    Questionable accounting or auditing practices; 
•    Dangerous practice likely to cause physical harm/damage to any person/property; 
•    Failure to rectify or take reasonable steps to report a matter likely to give rise to a significant and avoidable cost or loss to the Company; 
•    Abuse of power or authority for any unauthorized or ulterior purpose; 
•    Unfair discrimination in the course of the employment or provision of services. 

You can report an instance of wrongdoing by using our anonymous Legal and Ethical Complaints Form.

You can also report an instance of wrongdoing by calling our Legal and Ethical Complaints Hotline at 1-844-951-2799. Please note that your calls to this hotline will be traceable, and you will need to block your caller ID to maintain anonymity. 

All information you share with us, including your personal information and information relating to the complaint, will be kept confidential.

Corrective Action
Baylis responds to all instances of noncompliance using its Compliance Program Enforcement Protocol (CPEP), which is overseen by the Senior Legal Counsel. This mechanism uses risk-based, corrective, and preventative tools to address legal and regulatory instances of noncompliance, as well as breaches of our Code of Conduct and guidelines set out by AdvaMed and MedTech.