EXPERIANCE

My career in quality began 20 years ago when my education in the manufacturing industry focused on quality management.

My interest in this very important part of a product development phase process with medical device requirements according to the Directive and standard list below.

As quality manager I am very oriented to create lasting improvements, long-term business relationships and trust. My leadership can be described as both strong and humble, responsiveness and change of mind is also a guiding principle in my work.

My career is strictly targeted at quality improvement and governance by following ISO 13485/9001. More areas of quality according to current and previous job descriptions below.

WORK EXPERIENCE

FPQ-Consulting (Owner)

March 2014 - Ongoing

Quality manager for systems to develop Medical Devices since 2000.

This has given me 17 years of experience in the fields as follows:

CE marking of Medical devices class 1. 1s and class 2. Establishment of the Technical File, including Risk analysis according to EN 14971, labelling of sterile products according to EN 556-1 and EN 980 and packing of sterile products under the 11607 Maintenance and control of the Cleanroom Classified work area in accordance with ISO 14644 and 14698 during implementation of ISO 9001/13485.

The products CE marked has also been implemented in the organizations with the help of Validation System which is based on GHTF Validation guidance N99-10.

NEWS FR2000:

I had the opportunity to provide a company in the Medical Device to achieve the demands of the FR2000.

The company in question has previously been certified against 13485/9001 and was in need of an environmentally certified manufacturing process.

We first looked at enabling certification against 14001, but considering that the company in question is a small organization and a verification would entail significant costs for the company.

Then we looked at the FR2000 which county council accepts as a standard for meeting their environmental requirements and a certification was conducted with good results

FR2000: 2017 - is that it now ensures compliance to ISO 9001and ISO 14001.

More and more organizations meet demands from customers and other stakeholders to have a certified quality and environmental management system. At the same time, there are more than quality and environmental parts of the business that need to be organized and classified using classified procedures.

FR2000 Business Management is a standard that can be used by all types of organizations to create an integrated management system that demands quality, environment, work environment, fire protection and competence. The standard is educational flow-oriented and reflects an order's way through the organization, from quotation to completed business.

Regulatory Manager

S2 Medical AB

March 2020 - Ongoing

Quality Manager and Project leader

EuroForm Motala AB

March 2016 - February 2019 2 years 11 months)

Responsible for maintaining quality and environmental systems, 9001 and 14001, in the car-industry fabrication within company with TS classified manufacturing and development.

Quality Manager and Project leader

EuroForm AB/MediPharm AB

March 2014 - February 2020 (5 years 11 months)

Responsible for maintaining quality and environmental ,ISO 13485, systems in the medical device development and fabrication within company with cleanroom classified manufacturing and development and support the Project team as a Project leader.

Quality- and Environmental Manager

Cenova AB

December 2013 – February 2014 (1 year 2 months)

Responsible for maintaining quality and environmental systems in the medical device development and fabrication within company with cleanroom classified manufacturing and development.

Quality manager

Stebro Group AB

April 2011 – December 2012 (1 year 9 months)

Main responsibility for Quality and Environmental Systems for all companies within the group. Stebro Plastic AB, HYGE Plast and Veinge Plast. Within the group we initiate a common Quality and Environmental Management Systems Standards according to 9001, 13485, 14001 and OHSAS 18001

Quality manager

Inmedic AB (Hammarplast Medical AB/HPM)

March 2000 – March 2011 (11 years 1 month)

Quality Manager, Training Manager, Data Manager, Project Management. custom Medical Products with responsibility for CE marking of this regime. Establishment of the Technical File, including Risk analysis according to EN 14971, labeling of sterile products according to EN 556-1 and EN 980 and packing of sterile products under the 11607 Maintenance and control of the Cleanroom Classified work area in accordance with ISO 14644 and 14698 Implemented ISO 9001/13485 with its sister company Inmedic AS in Estonia.

Implementation of Validation System which is based on GHTF Validation guidance N99-10 for the plastic injection molding machines producing plastic parts for assembly on Inemdic AS.

Project manager at moving assembly line from Inmedic AB Inmedic AS in Tallinn.

Validation of all assembly processes, including mounting of plastic, function test and sterilization. Sterilization performed in Pärnu outside Tallinn and release of sterile performed at Inmedic AS.

Quality and Environmental Manager

AGÅ Maskiner AB

June 1999 – March 2000 (10 months)

Maintain and improve the existing quality and environmental management system in accordance with 9001 and 14001. Implementation of QS9000, today known as the ISO / TS 16949.  Responsible for internal audits within the Group and to share responsibility for outcomes testing in collaboration with other quality techniques in the group.

 

STANDARDS and DIRECTIVES

ISO 9001 Quality management systems

ISO 13485 Medical devices. Quality management systems -- Requirements for regulatory purposes

ISO 14971 Medical devices. Application of risk management to medical devices

ISO 14644-1 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

ISO 14644-2 Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

ISO 14644-3 Cleanrooms and associated controlled environments -- Part 3: Test methods

ISO 14698-1 Cleanrooms and associated controlled environments. Biocontamination control -- Part 1: General principles and methods

ISO 11607-1 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems

SS-EN 556-1 Sterilisering av medicintekniska produkter - Krav för märkning med symbolen "STERIL" - Del 1: Krav för medicintekniska produkter steriliserade i sluten förpackning

GHTF Validation guidance N99-10

1993: 584 Law on medical device

1993: 876 Regulation on medical devices

LVFS 2003: 11 Medicines Agency's regulations on medical devices

LVFS 2001: 5 Medicines Agency's regulations on active medical devices for

Implantation

LVFS 2001: 7 Medicines Agency's regulations on medical devices for in vitro diagnostics