Question: Niels Peter Louis-Hansen owns one-fifth of a medical device company that does what?

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Alvimedica: Alvimedica is a manufacturer of coronary stents, balloon catheters, diagnostic and guiding catheters.  The company was founded in 2007 by Turkish businessmen and scientists living in Denmark and Sweden.  The major intention of the company is investing in small and medium size medical device manufacturers to enable them to compete globally.  The company made its first investment move by purchasing a medical device company called Nemed in Turkey in 2007.  Following this, the company purchased an American company called In-Vivo, a manufacturer of angioplasty and angiography catheters, and one of the suppliers of Abbott Laboratories.

Safe Medical Device Amendments of 1990: Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act.  The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices.  The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product.

Karen Reynolds: Professor Karen Reynolds FTSE, FAHMS, FIEAust, PhD, MSc, MA, BA(Hons), Grad Cert Tert Ed is a highly awarded Australian Bio-medical Engineer.  She is currently the Deputy Dean of Computer Science, Engineering and Mathematics at Flinders University and a Matthew Flinders Distinguished Professor.  In addition to her teaching and research roles, Reynolds is the Director of the Medical Device Research Institute and founding Director of the Medical Device Partnering Program in South Australia; an organisation that facilitates collaboration between researchers, end-users and industry to assist in the development of cutting-edge medical devices that solve real end-user problems.  The Medical Device Partnering Program has assisted more than 150 companies and inventors since its creation in 2008, helping develop medical devices that improve diagnosis, treatment and rehabilitation of patients as well as providing greater independence for people with disability and older people.

Patient management software: Patient management software (PMS) is referred to as software that is regulated as a medical device.  It is software that is used to acquire medical information from a medical device to be used in the treatment or diagnosis of a patient.  It can also be software that is an adjunct to a medical device and directly contributes to the treatment of the patient by performing analysis, or providing treatment or diagnosis functionality that replaces the decision and judgment of a physician.

WuXi AppTec: WuXi AppTec Group (pronounced WOO-shee) is a global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform company that is pioneering a new model of open-access research for companies ranging from big pharma right through to a single researcher.  The WuXi Group offers an integrated portfolio of services to help worldwide customers and partners shorten discovery and development and lower the overall cost of drug and medical device R&D.  The company covers the entire development cycle through five core operations, including its capabilities in small molecule R&D and manufacturing, biologics R&D and manufacturing, cell therapy and gene therapy R&D and manufacturing, medical device testing, and molecular testing and genomics.  The WuXi platform is currently being used by over 3,000 innovative collaborators from more than 30 countries.

Stephen P. MacMillan: Stephen P. MacMillan is the Chairman, President, and Chief Executive Officer, and Director of Hologic, a medical device and diagnostic manufacturer headquartered in Marlborough, Massachusetts.  He was previously the Chairman of the Board, President, and Chief Executive Officer of Stryker Corporation, a global medical device company, and has 24 years of healthcare industry operating experience.  He served as Chief Executive Officer of Stryker from January 2005 to February 2012 and served as its President from June 2003 to February 2012.  During his tenure at Stryker, MacMillan successfully led the company through a series of key strategic acquisitions, the launch of a number of products within the orthopedic implants and medical instrumentation businesses, and delivered strong operating performance, with revenue growing from $2.8 billion to $8.3 billion, between 2003 and 2011.  During his tenure, Stryker delivered stock price appreciation of more than 62%, compared to appreciation of the S&P 500 index of approximately 40%.  While MacMillan presided as CEO, Stryker was selected by FORTUNE, over multiple consecutive years, as one of the "World's Most Admired Companies" in the Medical Equipment Industry.

Coloplast: Coloplast is a Danish multinational company that develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care.

Mölnlycke Health Care: Mölnlycke Health Care is a Swedish medical device company headquartered in Gothenburg and active internationally.  The company manufactures and sells wound care and single-use surgical products and is a service provider to the healthcare sector.  The surgical division includes medical devices such as drapes, gowns, facemasks, and headwear.  The wound care division includes medical device wound healing solutions such as dressings, compression products and skin care products and emollients.  Featured products in wound care include those with Safetac® technology available exclusively on Mepitel® , Mepilex® , and other dressings.  The wound care product assortment also includes WoundEL® electrostimulation for hard-to-heal wounds, wound dressings such as Mepore® , compression bandages, dermatology products and retention products such as Tubifast®.

Global Harmonization Task Force: The Global Harmonization Task Force (GHTF) was “a voluntary group of representatives from national medical device regulatory authorities (such as the U.S. Food and Drug Administration (FDA)) and the members of the medical device industry” whose goal was the standardization of medical device regulation across the world.  The representatives from its five founding members (the European Union, the United States, Canada, Japan and Australia) were divided into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.  Founded in 1992, the GHTF was created in “an effort to respond to the growing need for international harmonization in the regulation of medical devices."

Niels Peter Louis-Hansen: Niels Peter Louis-Hansen (born 1944) is a Danish billionaire businessman, deputy chairman and owner of one-fifth of the medical device company Coloplast.

Supporting paragraphs: Niels Peter Louis-Hansen Coloplast
Answer: develops, manufactures and markets medical devices and services related to ostomy, urology, continence, and wound care