Bioladders

Certification to ISO 9001:2008 is not considered an “upgrade”. The rules for transition are as follows:

1. The new edition will not require any specific reassessment for certification. Certification Bodies will evaluate conformity to the new ISO 9001:2008 standard during regular surveillance visits and full reassessment will only take place once your current certificate expires.

2. ISO and the IAF have agreed that all certificates to ISO 9001:2000 should be transitioned to ISO 9001:2008 within 2 years of publication date, (i.e., before November 14, 2010). Your organization can request your Certification Body to asses your QMS to ISO 9001:2008 at your next Surveillance audit.

3. One year after publication of ISO 9001:2008 (i.e., before November 14, 2009), all certifications issued (new certifications and re-certifications) must be to ISO 9001:2008.

4. Two years after publication of ISO 9001:2008 (i.e., before November 14, 2010), existing ISO 9001:2000 certifications will not be valid.

Tags: Interesting News, Quality Systems, Standards by Plato
2 Comments »

Tags: Interesting News, Quality Systems, Standards by Plato
No Comments »

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008

All changes between ISO 9001:2000 and ISO 9001:2008 are detailed in Annex B to ISO 9001:2008.

Tags: Interesting News, Quality Systems, Standards by Plato
No Comments »

Tags: GMP, Interesting News, Quality Systems, Training by Plato
No Comments »

Andrew Mickey writes about health care sector in seeking alpha

The market’s main focus is on what the latest government plan will look like when it’s revealed later this week (talk about dramatically shortened time horizons). But hey, this was expected. We knew the stimulus plan wasn’t worth much, and frankly, hopes of a government-orchestrated solution having any impact in a few months time were just irrational. But this is just what we’ve been waiting for.

As you’ll soon see, a very strong pocket of strength is forming in one sector, and it will be safe to jump in soon. It’s shaping up just as we’ve been expecting, but first we should go over a few areas the markets will be forced to “reckon” with over the next few months.

A few months ago, we questioned whether the markets really priced in 9% to 10% unemployment. It looks like the market is starting to get its first glimpse of what it will look like, and it doesn’t like what it sees.

There’s practically no reason to get excited about anything over the short term, and the analyst community (which seems like it’s always the last one to realize how bad things really are) is feeding a very hungry bear.

Over the weekend, Howard Silverblatt, an analyst for Standard & Poor’s, stated:

This is the worst; after the sixth quarter of negative growth, it will be the first quarter ever of negative earnings.

That’s just one realization the market has to go through yet. However, another, potentially bigger problem exists.

An Undeniable Pocket of Strength

There’s no side skirting this one. It’s ugly out there and it’s getting worse, with state budget deficits and a federal stimulus package doomed for failure, slowly but surely, the market is realizing the seriousness of the situation. There is, however, a good side to it all.

Remember a few weeks ago when we talked about how Barometer Capital’s little known, but highly successful David Burrows focuses on finding strength and buying it.

Well, we’re seeing a pocket of strength emerge right now. In the chart below there is a clear separation between the S&P 500 - gold line and iShares Dow Jones Medical Devices (IHI) – black line.

[Read more →]

Tags: Interesting News by Plato
No Comments »

View Larger Map

Top medical device companies from around the world have established a presence in Finland to develop, manufacture or market their products. This includes setting up their own subsidiaries to penetrate local markets and to build relations with end‐product users.

Philips Medical Systems
Philips Medical Systems MR Technologies Finland Oy develops and manufactures magnetic imaging systems based on Finnish technology for the world’s medical equipment markets. Established in 1993, the company also delivers software, RF‐technology, digital‐ and power electronics, mechanics, imaging methods and methods for image processing for the MRI systems. Over 150 employees are based in Finland and about half of them work in the product development department. Key market: USA.

GE Healthcare
GE Healthcare Finland Oy develops and manufactures imaging diagnostic systems, clinical systems and biopharmaceutical medical diagnostics.

Siemens Medical Solutions
Siemens Medical Solutions, one of the world’s largest suppliers to the healthcare industry, has an active sales representation in Finland through its Swedish subsidiary. Its medical solutions include imaging systems, information systems and technical services. The Siemens Ab Finnish sales office employs over 40 people and the turnover in 2003 was 14 million Euros.

Toshiba Medical Systems
-Toshiba Medical Systems has its own sales, service and support organization in Finland, with a focus on ultrasound systems, x‐ray systems and MRI systems.

Baxter
Baxter International, a global healthcare giant, sells and markets pharmaceuticals and medical devices in Scandinavia in 4 divisions. The Finnnis division employs 30 people out of 200 in Scandinavia. Last reported turnover of Baxter Finland was 26,7 million Euros.

Tags: Company Directory, Interesting News by Plato
No Comments »

Top Biotech Schools (Private Sector)

1. School of Chemical and Biotechnology Sastra University Thanjavur, Tamilnadu

2. Department of Biotechnology, SRM University, Chennai

Click here for full article

[Read more →]

Tags: Indian Biotech, Interesting News by Plato
No Comments »

The number of biotech companies in Canada has soared more than 75% in the past 20 years, and they are spread out across the country. In fact, Canada has become a training ground for leaders, exporting talent to the rest of the world. What’s more, it leads the world in the opportunities available to women. [Read more →]

Tags: Indian Biotech, Interesting News by Plato
No Comments »

Currently, FDA lacks a mechanism to approve or evaluate a material independently from a medical device—and that creates problems.  Most materials used today existed for decades, so it might have created a little bit of complacency on FDA’s side. But the lack of such a mechanism to evaluate materials creates a disincentive for developing new, novel materials.

Tags: FDA, Interesting News by Plato
No Comments »

Bio Spectrum is India’s first monthly comprehensive Biotech business magazine covers the entire happenings in the exciting areas of BioPharma, BioAgriculture,BioInformatics, BioIndustrial, BioSuppliers and BioServices.  Biospectrum surveyed in both public and private sector biotechnology schools in India in 2008. The research team spent considerable amount of time accurately analyzing the filled in data for each institute. For each institute, a score was arrived at for each parameter. For a particular parameter, the score was a composition of each of the sub-parameters. Faculty, Infrastrucure, placement and industry interaction are the main parameters.

[Read more →]