Outsourcing – a Smooth Operation

Outsourcing is often a cost efficient solution. QMS is no exception. When Otovation decided to outsource their quality management for their entire line of equipment for hearing aids, they chose Medicologic as a partner.

Quality management is essential in the medical device industry as the prerequisite for permission to market products as stated for instance in the EU Medical Device Directive (MDD).

With ever-changing standards and regulatory demands from the health authorities, staying updated can be quite a demanding task for a company’s quality management department. Rather than building and maintaining this expertise in-house, you can hire it from a consultant.

In Otovation’s case the choice of an external consultant made sense from a financial point of view.

– It made sense to us to rely on outsourcing. Rather than having QMS weigh on the budget as a fixed expense, outsourcing meant that we only had to pay for specific services from our consultant. In this case, we needed someone to manage and guide our production with respect to the proper documentation in accordance with EU & FDA and global standards, says Lene Ploug Bülow, General Manager, Otovation.

– We had a previous relationship with CEO Michael Funder at Medicologic and were aware that they could offer consultancy in regulatory matters. When we decided to outsource quality management, I suggested to our Quality Manager that he consider Medicologic as a possible partner. We also viewed other potential suppliers, but found that Medicologic offered the best solution. Looking back, I must say that the collaboration ran smoothly and to our full satisfaction.

Besides using a consultant as Medicologic as an ad hoc quality management department, an external consultant can help slim down manuals and procedures. The challenge with QMS often is that it becomes too complex. When procedures become very voluminous, they lose their user-friendliness and effectiveness. Revising such procedures and splitting them into an overall procedure, associated instructions and templates can improve the user-friendliness and recreate the effectiveness of the quality system.

– A fresh perspective is always beneficial at an internal audit of the QMS. Even when you use a consultant to revise the QMS I believe you could benefit from getting a fresh view occasionally, says Senior Quality Consultant, Per Maegaard, Medicologic.

Medicologic also has developed full Quality Management Systems for medical device manufacturers to obtain certification to ISO standards.

Contact
Asger Dahlgaard, Program Manager, ad@medicologic.com, Direct (+45) 22 47 41 06
Per Maegaard, Senior Quality Consultant, pma@medicologic.com, Direct (+45) 22 47 09 52