A quick reminder, what does Jute medical do?

Simply put:

Jute medical is a reactive service that performs pickup, technical analysis and reporting of medical devices that are thought to have been involved in incidents.

Key issues

Unique problems arising from PMS requirements

• When issuing new products to the market, there are often increased PMS requirements as market safety must be more excessively monitored during initial periods.
• Providing PMS in different countries can prove difficult when nobody is based within that country; for example device sterilisation and international transportation issues.
• The irregular nature of PMS work can provide difficulties as employees may not be able to find time to quickly handle the increased workload.

QMS and legislation suitability issues (in terms of outsourcing)

The QMS system and legislatory requirements that must be in place for a medical device manufacturer are complicated to say the least. You may be surprised to learn however, that these problems can be simply addressed by:

• Making the appropriate notified bodies aware of your intentions to outsource (including details on the nature of the change.)
• Ensuring that an “External providers assessment” (or equivalent) is undertaken.

Please consult the guidance document - Conformity assessment procedure - Subcontracting quality systems related - MEDDEV 2.5/3 rev.2 for more information.

Pros of outsourcing

Let’s look at the potential benefits of outsourcing:

You are not hiring an employee
Hiring an employee is a long-term solution, so when you are faced with a short-term problem, outsourcing may be the best option.

Efficiency savings
During high workload periods, staff will be under increased pressure to perform a larger variety of tasks in less time. This kind of strained work leads to mistakes and lower work output. Outsourcing reduces the load on staff.

Access to skilled work
Immediate access to skilled work can be very beneficial to a company without it.

Cost lowering
Spending money to save money sounds great, because it is great!

Quick setup
Depending on the type of service you are attempting to setup, you may find that it is easier to setup and start work with an outsourcer than within your own company

Work termination
When the need for outsourcing has expired, ending the work is simpler with contractors rather than employees.

Core activities and staff flexibility
Keeping staff away from a business’s “core activities” can have a disproportionate effect on the functioning of the company. Outsourcing allows key staff to be where they are needed the most.

Cons of outsourcing

Let’s look and the problems thought to be involved in outsourcing:

Loss of control
The employer may find that the level of control over their subcontractor’s work may differ from that from within their company.