Your Life Sciences Business: Guidance, Updates and Resolutions You Can Keep

Fresh starts and new beginnings. That’s how we seek to approach each new calendar year. Personally we proclaim resolutions and set goals for ourselves: to read more, exercise or eat healthier.

Professionally we build business plans, and set sales or production goals. While there’s plenty to plan and prepare for in 2017, take note of the following resolutions for your life science business that are worth sticking to throughout the year ahead.

  1. Prepare for the transition to ISO 13485:2016 An update to ISO 13485:2003 was issued in March 2016, with a three-year timeline for simultaneous existence of guidance for either certification. After the third year, certifications issued to ISO 13485:2003 will no longer be valid. The changes include increased emphasis on Quality Management Systems throughout the supply chain, thorough post-market surveillance and customer complaint handling and reporting. Read more here on the changes and guidance.
  2. Plan for proposed FDA Guidance The FDA Center for Devices and Radiological Health (CDRH) have published a list of guidance documents the organization intends to review and issue for the 2017 Fiscal Year. The list is broken down by priority with an “A” list containing documents fully intended to be published; followed by the “B” list, items that are intended to be published as resources permit. Finally, final documents issued in previous years will be reviewed and assessed. As always, the FDA is open to comments on the guidance and the process continues. Interested if a document that will impact your business is on the list? You can find the entire list and ways to provide feedback on the FDA’s site.
  3. Cyber-security guidance, and general concerns, are not going away: be prepared. The FDA issued guidance on the management of cyber security in premarket submissions in 2014. It has now issued final guidance on the post market management of cyber security. There have been concerns in the last couple of years that medical devices have increased in their connectivity and use of the internet, however security measures have not kept pace-creating vulnerabilities for health care facilities and patients. Manufacturers are encouraged to consider cyber security throughout the life cycle of a device. Med Device Online presents a thorough recap of the guidance, in the event you’re not ready for the 30 page document from the FDA. The FDA guidance isn’t the only reason to be cognizant of cyber threats. Cyber criminals find a multitude of ways into your computer system; whether it’s for personal information, credit cards, or to hold data ransom for a monetary payment from you. Don’t think it “can’t happen to me” make a plan so you know how to respond for when, not it.

Not sure where to start with the new guidance documents or how to build a plan to get you ready for new standards?

Follow @OswaldLifeSci on Twitter for updates as this continues to evolve. 

For further information, view the article the Top 3 Year-end Tax Planning Ideas for Startups on the Skoda Minotti blog.


Note: This communication is for informational purposes only. Although every reasonable effort is made to present current and accurate information, Oswald makes no guarantees of any kind and cannot be held liable for any outdated or incorrect information.