Another challenge to the world’s most highly regulated industry – hazardous substances environmental regulations.

There is a widely-held myth that pharmaceuticals, biotechnology and medical devices are exempt from RoHS, REACH, Proposition 65 or other similar environmental regulations.

You have received your CE mark, USFDA 510k or Canadian Medical Device License; your quality system has been registered to CMDCAS and EN/ISO harmonized standards; your design dossier has been reviewed and approved, you have complied with dozens of international, regional and harmonized standards and guidelines and you still cannot get market access… why? Because your product is not exempt and you have been asked to supply environmental compliance documentation!

Contact Horizon Phoenix for answers to key environmental issues:

• What regulations affect me today? What ones are in the transition period and will affect me in the next few months or years?
• What options are available to me to demonstrate compliance?
• How detailed does my due diligence process have to be to protect my market access?
• I outsource to contract manufacturers and service providers, do I still have environmental obligations?

How Can Horizon Phoenix Help You?

As medical device experts, we understand you simply cannot change your devices without affecting your current product approvals, design dossiers or licenses. We understand how carefully changes must be implemented. We will train your staff to ensure that expertise and knowledge on environmental requirements reside inside your company. We will help you chart an effective path forward to meeting and exceeding all regulatory requirements, including these environmental requirements! Horizon Phoenix experts will keep you moving forward maintaining market access and your current regulatory approvals while meeting your environmental obligations.

Contact Horizon Phoenix for more information.

Complying with Environmental Regulations preserves our
environment for future generations...