Dealing with Transactional Compliance in the Medical Device Industry

Written by GCO

November 8, 2021

To outsource or not, that’s the question

Following the trend of the public to have a ‘right to know,’ medical device companies are implementing robust compliance and transparency programs. Picking up on the confidence transparency instils in the public towards the European institutions and realizing they are critical success factors for operating a successful business model.

Having a track record of 30 years in the highly regulated environment of Life Sciences, we know how to develop effective, practical, and efficient compliance programs. For a Medical Device company, a good compliance approach leads to risk mitigation, as breaches of codes and laws are being averted. Being compliant is also essential to ethical business practices in general and, in particular, interactions with Healthcare Professionals (HCPs).

All Medical Device companies consider compliance with transparency laws and codes a fundamental part of their business. At @GCO, we notice a trend where companies are looking for efficient ways to cope with the workload created by complying with those laws and codes. For example, company staff needs to be continuously trained to be (and stay) fully updated concerning the rules and regulations. Moreover, it requires a considerable effort to track and publicly report the payments made to healthcare professionals and organisations on an administrative level. Proper process implementation and appropriate support from IT systems where required can create efficiency and significantly unburden staff.

The demand for increased transparency and openness coming from various EU Regulatory Agencies is causing public data access and requests to become the new norm. These demands, coupled with the more extensive proactive data dissemination, the workload and time investment are not likely to be reduced in the future. For operating a successful business model, the industry realizes that compliance and transparency are both critical success factors.

Therefore, more and more Life Science companies outsource their transactional compliance and transparency activities to our team of Medtech certified compliance experts, who can support you in creating the right SOPs; provide you with the correct and applicable templates; draft the appropriate contracts; and provide advice on the codes and laws on a country-by-country basis.

While outsourcing this expertise to GCO as a trusted partner, our clients can focus on what they are best at, bringing Life Science innovations to their patients.

Marlize Eckert

Marlize Eckert

Business Unit Lead Compliance

For operating a successful business model, the industry realizes that compliance and transparency are both critical success factors.

 

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